Delivery devices and methods for gastrointestinal implants

ABSTRACT

Several gastrointestinal surgery procedures are effective as treatments for metabolic disorders such as obesity and diabetes. Minimally invasive procedures including intra-luminal gastrointestinal implants have been proposed to mimic the anatomical, physiological and metabolic changes achieved by these procedures. Many of these designs include long sleeve like elements that prevent contact of food with the walls of the small intestine. It is desirable to have simple delivery systems that can place these implants under endoscopic guidance. However, in order to anchor these sleeve elements safely and reliably, the inventors have previously disclosed anchoring means that anchor the sleeves at the junctions of the stomach and the intestine or the stomach and esophagus.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit under 35 U.S.C. section 119(e) ofU.S. provisional patent application 61/626,658, filed Sep. 30, 2011.This application is a continuation-in-part of each of the followingapplications, each of which are hereby incorporated by reference intheir entirety: (1) U.S. patent application Ser. No. 13/493,144, filedJun. 11, 2012, which is a divisional of U.S. patent application Ser. No.12/752,697, filed Apr. 1, 2010, which claims the benefit of U.S.provisional patent application 61/211,853, filed Apr. 3, 2009 (nowgranted as U.S. Pat. No. 8,211,186); (2) U.S. patent application Ser.No. 12/833,605, filed Jul. 9, 2010, which claims the benefit of U.S.provisional patent application 61/270,588, filed Jul. 10, 2009; (3) U.S.patent application Ser. No. 12/986,268, filed Jan. 7, 2011, which claimsthe benefit of U.S. provisional patent application 61/335,472, filedJan. 7, 2010; (4) U.S. patent application Ser. No. 13/298,867, filedNov. 17, 2011, which claims the benefit of U.S. provisional patentapplication 61/458,060, filed Nov. 17, 2010; and (5) U.S. patentapplication Ser. No. 13/360,689, filed Jan. 28, 2012, which claims thebenefit of U.S. provisional patent application 61/462,156, filed Jan.28, 2011, and U.S. provisional patent application 61/519,507, filed May24, 2011.

TECHNICAL FIELD

This invention generally relates to implants placed withingastrointestinal systems, including the esophagus, the stomach and theintestines. In particular it relates to implant systems havingcomponents implantable and removable using endoscopic techniques fortreatment of obesity, diabetes, reflux, gastroparesis and othergastrointestinal conditions.

BACKGROUND

Bariatric surgery procedures, such a sleeve gastrectomy, the Rouen-Ygastric bypass (RYGB) and the bileo-pancreatic diversion (BPD), modifyfood intake and/or absorption within the gastrointestinal system toeffect weight loss in obese patients. These procedures affect metabolicprocesses within the gastrointestinal system, by either short circuitingcertain natural pathways or creating different interaction between theconsumed food, the digestive tract, its secretions and theneuro-hormonal system regulating food intake and metabolism. In the lastfew years there has been a growing clinical consensus that obesepatients who undergo bariatric surgery see a remarkable resolution oftheir type-2 Diabetes Mellitus (T2DM) soon after the procedure. Theremarkable resolution of diabetes after RYGB and BPD typically occurstoo fast to be accounted for by weight loss alone, suggesting there maybe a direct impact on glucose homeostasis. The mechanism of thisresolution of T2DM is not well understood, and it is quite likely thatmultiple mechanisms are involved.

One of the drawbacks of bariatric surgical procedures is that theyrequire fairly invasive surgery with potentially serious complicationsand long patient recovery periods. In recent years, there is anincreasing amount of ongoing effort to develop minimally invasiveprocedures to mimic the effects of bariatric surgery using minimallyinvasive procedures. One such procedure involves the use ofgastrointestinal implants that modify transport and absorption of foodand organ secretions. For example, U.S. Pat. No. 7,476,256 describes animplant having a tubular sleeve with anchoring barbs, which offer thephysician limited flexibility and are not readily removable orreplaceable. Moreover, stents with active fixation means, such as barbsthat deeply penetrate into surrounding tissue, may potentially causetissue necrosis and erosion of the implants through the tissue, whichcan lead to complications, such as bacterial infection of the mucosaltissue or systemic infection. Also, due to the intermittent peristalticmotion within the digestive tract, implants such as stents have atendency to migrate.

Gastroparesis is a chronic, symptomatic disorder of the stomach that ischaracterized by delayed gastric emptying in the absence of mechanicalobstruction. The cause of gastroparesis is unknown, but it may be causedby a disruption of nerve signals to the intestine. The three most commonetiologies are diabetes mellitus, idiopathic, and postsurgical. Othercauses include medication, Parkinson's disease, collagen vasculardisorders, thyroid dysfunction, liver disease, chronic renalinsufficiency, and intestinal pseudo-obstruction. The prevalence ofdiabetic gastroparesis (DGP) appears to be higher in women than in men,for unknown reasons.

Diabetic gastroparesis affects about 40% of patients with type-1diabetes and up to 30% of patients with type-2 diabetes and especiallyimpacts those with long-standing disease. Both symptomatic andasymptomatic DGP seem to be associated with poor glycemic control bycausing a mismatch between the action of insulin (or an oralhypo-glycemic drug) and the absorption of nutrients. Treatment ofgastroparesis depends on the severity of the symptoms.

Several inventors have recently described intra-luminal implants andimplant delivery tools to mimic the effect of bariatric surgeryprocedures such as gastric and intestinal bypass for the treatment ofobesity. In particular to mimic the effects of a popular surgicalprocedure called the Rouen-Y Gastric bypass in which most of the stomachis excised and a lower part of the small intestine is anastamosed to asmall stomach pouch, several inventors have proposed implants thatanchor at the gastroesophageal junction and reroute food to the smallintestine. In many instances these implants then also anchor sleeves orstented sleeves that act as bypass conduits for mimicking stomach andintestinal bypass surgeries.

These systems, however, have significant shortcomings in terms ofclinical side effects and complications. Implants that bypass thestomach with artificial sleeve like structures or conduits do not havemotility like in a surgical gastric bypass where the anastomosed sectionof the intestine actively propels food from the esophagus (e.g., thesystem described in U.S. Pat. No. 7,837,669). Hence in early clinicalresults using this approach patients have complained about dysphagia(difficulty swallowing) as the solid undigested food is not easilypushed forward in to the small intestine from the esophagus throughthese artificial passageways. Also, the delivery system contemplated tobe used to perform this procedure is complicated (e.g., U.S. PatentPublication 2008/0167606). It involves placing a sleeve element into thesmall intestine, where the sleeve element is first delivered in asock-like configuration and then is extended into the small intestine byunrolling it. Accurate placement with this system is difficult.

SUMMARY

According to various embodiments, the present invention provides for anapparatus and method to place and anchor an intestinal bypass sleevewithin one or more of the pyloric antrum, the pylorus, the duodenum andthe jejunum. The gastrointestinal implant herein disclosed can beinserted endoscopically (when the device is loaded into a deliverycatheter) through the mouth, throat, stomach and intestines. Thegastrointestinal implant device includes a flexible thin-walled sleeveand an expandable anchor attached to the proximal end of the sleeve;secondary anchors may also anchor other portions of the thin-walledsleeve.

The present invention herein disclosed (with a short bypass sleeve or nobypass sleeve) can also be used to hold open the pylorus and may help toreduce the symptoms of gastroparesis, by allowing the stomach contentsto exit the stomach easier through the pylorus into the duodenum. Anactive pumping means may also be attached to the expandable anchor toactively pump the stomach contents from the pyloric antrum into theduodenum.

According to various embodiments, the delivery system includes a thinsleeve element having a proximal anchoring element attached to it anddistal end that is open. A single or multi-lumen sleeve deliverycatheter carries the sleeve element by being releasably attached to itsdistal end, but the delivery catheter does not pass through the lumen ofthe sleeve. A multi-lumen implant delivery catheter with a distal end inthe form of a capsule that can accommodate the anchoring implant withinits bore. A mechanical retention feature releasably attaches the distalend of the sleeve element to the distal end of the cathete.

According to various embodiments, a method of using this delivery systemto deliver an implant for creating an intestinal bypass includes (1)introducing an endoscope within the stomach, (2) placing a guide wirethrough the lumen of the endoscope and placing it past the pylorus in tothe small intestine under endoscopic and or fluoroscopic guidance, (3)withdrawing the endoscope out the patient, (4) placing the implantdelivery catheter system that is pre-loaded with a sleeve deliverycatheter and the sleeve element (including the proximal anchoringelement) over the guide-wire in to the stomach, (5) advancing the sleevedelivery catheter which extends beyond the implant delivery catheterwith the sleeve in to the small intestine so that its distal end is atthe position where you want to locate the distal end of the sleeve andthe capsule is correctly positioned at the pylorus under endoscopicand/or fluoroscopic guidance, (6) rentroducing the endoscope in to thestomach adjacent to the capsule at the distal end of the implantdelivery catheter, (7) releasing the distal end of the sleeve byactivating a release mechanism, (8) retracting the sleeve deliverycatheter and the guide wire to a position proximal to the capsule, (9)deploying the intestinal side of the anchoring element with an actuatorcarried in one of the lumens in the implant delivery catheter, (10)deploying the stomach side of the anchoring element either with anactuator carried in one of the lumens in the implant delivery catheteror by retracting the entire implant delivery system backwards towardsthe mouth of the patient, and (11) withdrawing the endoscope, the guidewire and the implant delivery system out of the patient.

While multiple embodiments are disclosed, still other embodiments of thepresent invention will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the invention. Accordingly, the drawings anddetailed description are to be regarded as illustrative in nature andnot restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-sectional view of a portion of the digestive tract ina human body with an intestinal bypass sleeve implanted in the duodenumfrom the pylorus to the ligament of Treitz. The sleeve is held in placeat the pylorus by an expandable anchor that anchors on the pylorus.

FIG. 2 is a cross-sectional view of a portion of the digestive tract ina human body with an endoscope inserted through the mouth, esophagus andstomach to the pylorus.

FIG. 3 is a drawing of an expandable anchor according to exemplaryembodiments of the invention.

FIG. 4 is a cross-sectional drawing of the pyloric antrum, pylorus,duodenal bulb and duodenum. An expandable anchor and intestinal bypasssleeve is implanted into the pylorus.

FIG. 5 is a drawing of an alternative embodiment of the invention hereindisclosed. The expandable anchor is comprised of a hollow tubularbraided structure of wire. The wire form has been shaped to conform tothe shape of the pylorus and the duodenal bulb.

FIG. 6 is a sectional view of an alternative embodiment of an anchor andsleeve implanted into the pylorus and duodenal bulb and duodenum.

FIG. 7 is a drawing of an alternative embodiment of an expandableanchor. The expandable anchor is comprised of two toroidally shapedwound springs connected to a central cylinder by control arms.

FIG. 8 is a drawing of a flat representation of the control arms andcentral cylinder as in FIG. 7 as laser cut from a piece of tubing.

FIG. 9 is a drawing of a heat set mandrel used for heat setting orforming the FIG. 8 part into the final shape of expandable anchor inFIG. 7

FIG. 10 is drawing of the control arms heat set to the final shapebefore the toroidally shaped wound springs are assembled on the controlarms.

FIG. 11 is a drawing of an alternative embodiment of a central cylinderand control arms.

FIG. 12 is a drawing of the toroidally wound springs in a straightconfiguration, before the toroidally wrapped spring is assembled ontothe control arms.

FIG. 13 is a drawing of alternative embodiments of toroidally woundsprings.

FIG. 14 is a drawing of an alternative embodiment of a central cylinderand control arms.

FIG. 15 is a drawing of an expandable anchor and intestinal bypasssleeve.

FIG. 16 is a sectional view of the expandable anchor as in FIG. 7 andintestinal bypass sleeve implanted across the pylorus.

FIG. 17 is a sectional view of the expandable anchor and the intestinalbypass sleeve implanted into the duodenal bulb.

FIG. 18 shows a drawing flat representation of an alternative embodimentof the control arms and central cylinder as laser cut from a piece oftubing. The final heat set shape will be similar to the shape in FIG.23.

FIG. 19 shows a drawing flat representation of an alternative embodimentof the control arms and central cylinder as laser cut from a piece oftubing. The final heat set shape will be similar to the shape in FIG.23.

FIG. 20 is a drawing flat representation of an alternative embodiment ofthe control arms and central cylinder as laser cut from a piece oftubing. The final heat set shape will be similar to the shape in FIG.23.

FIG. 21 is a drawing of an alternative embodiment of an expandableanchor. The expandable anchor is comprised of two toroidally shapedwound springs connected to a central cylinder by control arms.

FIG. 22 is a drawing of an alternative embodiment of an expandableanchor. The expandable anchor is comprised of two toroidally shapedwound springs connected to a central cylinder by control arms.

FIG. 23 is a drawing of an alternative embodiment of an expandableanchor. The expandable anchor is comprised of two toroidally shapedwound springs connected to a central cylinder by control arms.

FIG. 24 is a drawing of an alternative embodiment of control arms.

FIG. 25 is a drawing of an alternative embodiment of a central cylinder.

FIG. 26 is a drawing showing two pieces of FIG. 24 and FIG. 25 assembledtogether with two toroidal shaped springs.

FIG. 27 is a drawing of alternative embodiments of a central cylinder.

FIG. 28 is a drawing of an expandable anchor in which the centralcylinder is adjustable in length.

FIG. 29 is a drawing of an expandable anchor as herein disclosed inwhich the expandable anchor is secondarily anchored to the pylorus,duodenal bulb or pyloric antrum by secondary means.

FIG. 30 is a drawing of an expandable anchor in which portion of thecentral cylinder is soft and conformable and allows the pylorus to openclose with the membrane on the central cylinder.

FIG. 31 is a drawing of an expandable anchor and an intestinal bypasssleeve. An optional anti-reflux valve and restrictor valve have beenincorporated into the central cylinder.

FIG. 32 is a drawing of an over the wire delivery catheter for placingthe expandable anchor and intestinal bypass sleeve within the digestivetract.

FIG. 33 is a drawing of a distal capsule tip for the delivery catheteras shown in FIG. 32.

FIG. 34 is a drawing of an inflatable balloon tip for the distal capsuleof the delivery device as shown in FIG. 32.

FIG. 35 is a drawing of a delivery catheter for placing the expandableanchor and intestinal bypass sleeve within the digestive tract. Thedelivery catheter has a retainer to prevent premature deployment of theexpandable anchor and to allow it to be re-sheathed to adjust theplacement location within the body.

FIG. 36 is a drawing of a distal end of a delivery catheter and anexpandable anchor and intestinal bypass sleeve.

FIG. 37 is a drawing of a delivery catheter for placing the expandableanchor and intestinal bypass sleeve within the digestive tract.

FIG. 38 is a drawing of a delivery catheter for placing the expandableanchor and intestinal bypass sleeve within the digestive tract.

FIG. 39 is a drawing of a delivery catheter for placing the expandableanchor and intestinal bypass sleeve within the digestive tract.

FIG. 40 is a drawing of an over the wire sleeve delivery catheter forplacing an intestinal bypass sleeve within the intestine.

FIG. 41 is a drawing of a monorail sleeve delivery catheter for placingan intestinal bypass sleeve within the intestine.

FIG. 42 is a drawing of an over the wire sleeve delivery catheter forplacing an intestinal bypass sleeve within the intestine.

FIG. 43 is a drawing of a delivery catheter for placing the expandableanchor and intestinal bypass sleeve within the digestive tract.

FIG. 44A is a drawing of an over the wire balloon catheter that is usedas a sleeve delivery catheter for placing an intestinal bypass sleevewithin the intestine.

FIG. 44B is a drawing of a monorail balloon catheter that is used as asleeve delivery catheter for placing an intestinal bypass sleeve withinthe intestine.

FIG. 45A is a drawing of the sleeve delivery catheter of FIG. 44A inwhich the intestinal bypass sleeve has been attached to the ballooncatheter.

FIG. 45B is a drawing of the sleeve delivery catheter of FIG. 44A inwhich the intestinal bypass sleeve has been released from the ballooncatheter.

FIG. 45C is a drawing of the monorail sleeve delivery catheter of FIG.44B in which the intestinal bypass sleeve has been attached to theballoon catheter.

FIG. 46 is a drawing of a sleeve delivery catheter.

FIG. 47 is a drawing of a guide wire to be used for placing expandableanchors and intestinal bypass sleeves.

FIG. 48A is a cross-sectional view of a portion of the digestive tractin a human body with an endoscope inserted through the mouth, esophagusand stomach to the pylorus.

FIG. 48B is a cross-sectional view of a portion of the digestive tractin a human body with an endoscope inserted through the mouth, esophagusand stomach to the pylorus. A guide wire is inserted through the workingchannel of the endoscope. The guide wire is advanced distally in thesmall intestine lumen into the jejunum.

FIG. 49A is a cross-sectional view of a portion of the digestive tractin a human body with an endoscope inserted through the mouth, esophagusand stomach to the pylorus. The guide wire of FIG. 47 is back loadedinto the working channel of the endoscope. The guide wire of FIG. 47 isadvanced distally in the small intestine lumen into the jejunum.

FIG. 49B is a cross-sectional view of a portion of the digestive tractin a human body with an endoscope inserted through the mouth, esophagusand stomach to the pylorus. The guide wire of FIG. 47 is left in placein the jejunum while the endoscope is withdrawn from the body. Theendoscope is then reinserted into the stomach through the mouth andesophagus parallel to the guide wire, but the guide wire is not in theworking channel of the endoscope.

FIG. 50A is a continuation in the deployment sequence from FIG. 49B. Anexpandable anchor and intestinal bypass sleeve has been loaded on todelivery catheter. The delivery catheter is advanced over the guide wirethrough the mouth, esophagus, Stomach and small intestine until thedistal end of the sleeve reaches the desired implant location.

FIG. 50B is a continuation in the deployment sequence from FIG. 50A. Thesleeve delivery catheter is actuated to release the distal end of thebypass sleeve from the catheter. The sleeve delivery catheter is thenretracted to remove it partially or fully from the digestive system. Thedistal capsule of the delivery system then is partially retracted todeploy or release the distal end of the expandable anchor from thedistal capsule.

FIG. 51 is a continuation in the deployment sequence from FIG. 50B. Thedistal capsule of the delivery system is fully retracted to deploy orrelease the proximal end of the expandable anchor from the distalcapsule. The expandable anchor and intestinal bypass sleeve are now inplace at the intended implant location. The ball on the end of the guidewire is released. The guide wire, delivery catheter and endoscope arewithdrawn from the human body.

FIG. 52 is a drawing of a monorail delivery catheter for placing anexpandable anchor and intestinal bypass sleeve within the digestivetract.

FIG. 53A is a cross-sectional view of a portion of the digestive tractin a human body with an endoscope inserted through the mouth, esophagusand stomach to the pylorus.

FIG. 53B is a cross-sectional view of a portion of the digestive tractin a human body with an endoscope inserted through the mouth, esophagusand stomach to the pylorus. A guide wire is inserted through the workingchannel of the endoscope. The guide wire is advanced distally in thesmall intestine lumen into the jejunum.

FIG. 54A is a cross-sectional view of a portion of the digestive tractin a human body with an endoscope inserted through the mouth, esophagusand stomach to the pylorus. The guide wire of FIG. 47 is back loadedinto the working channel of the endoscope. The guide wire of FIG. 47 isadvanced distally in the small intestine lumen into the jejunum.

FIG. 54B is a cross-sectional view of a portion of the digestive tractin a human body with an endoscope inserted through the mouth, esophagusand stomach to the pylorus. The guide wire of FIG. 47 is left in placein the jejunum while the endoscope is withdrawn from the body. Theendoscope is then reinserted into the stomach through the mouth andesophagus parallel to the guide wire, but the guide wire is not in theworking channel of the endoscope.

FIG. 55 is a continuation in the deployment sequence from FIG. 54B. Anexpandable anchor and intestinal bypass sleeve has been loaded onto amonorail delivery catheter. The delivery catheter is advanced over theguide wire through the mouth, esophagus, stomach and small intestineuntil the distal end of the sleeve reaches the desired implant location.

FIG. 56A is a continuation in the deployment sequence from FIG. 55. Thesleeve delivery catheter is actuated to release the distal end of thebypass sleeve from the catheter. The sleeve delivery catheter is thenretracted to remove it partially or fully from the digestive system. Thedistal capsule of the delivery system then is partially retracted todeploy or release the distal end of the expandable anchor from thedistal capsule.

FIG. 56B is a continuation in the deployment sequence from FIG. 56A. Thedistal capsule of the delivery system is fully retracted to deploy orrelease the proximal end of the expandable anchor from the distalcapsule. The expandable anchor and intestinal bypass sleeve are now inplace at the intended implant location. The ball on the end of the guidewire is released. The guide wire, delivery catheter and endoscope arewithdrawn from the human body.

FIG. 57 is a drawing of a catheter for removal of an expandable anchorand bypass sleeve as in FIG. 16 from the human body.

FIG. 58 is a drawing of a monorail guide eyelet that may be attached tothe end of the endoscope.

FIG. 59 is a drawing of a monorail guide eyelet that may be incorporatedinto the distal capsule of the expandable anchor delivery device.

FIG. 60 is a drawing of the expandable anchor herein disclosed implantedacross a pylorus. An external band has been surgically placed with alaparoscope around the pylorus. The band around the pylorus willincrease the radial compliance/stiffness of the pylorus and will providefor an increased force to cause dislodgment of the expandable anchorfrom within the pylorus.

FIG. 61 is a cross-sectional view of a portion of the digestive tract ina human body. An intestinal bypass sleeve is implanted in the duodenumfrom the pylorus to the ligament of Treitz. The sleeve is held in placeat the pylorus by an expandable anchor that anchors on the pylorus,optional secondary expandable anchors anchor the sleeve at additionallocations in the duodenum and jejunum. An expandable anchor with ananti-reflux valve is implanted at the gastroesophageal (GE) junction tohelp resolve gastroesophageal reflux disease (GERD).

FIG. 62 is a drawing of a deployment handle for a delivery catheter forexpandable anchors and intestinal bypass sleeves.

FIG. 63 is a drawing of a deployment handle for a delivery catheter forexpandable anchors and intestinal bypass sleeves.

FIG. 64 is a drawing of a deployment handle for a delivery catheter forexpandable anchors and intestinal bypass sleeves.

While the invention is amenable to various modifications and alternativeforms, specific embodiments have been shown by way of example in thedrawings and are described in detail below. The intention, however, isnot to limit the invention to the particular embodiments described. Onthe contrary, the invention is intended to cover all modifications,equivalents, and alternatives falling within the scope of the inventionas defined by the appended claims.

DETAILED DESCRIPTION

FIG. 1 is a sectional view of an embodiment of the invention implantedin a portion of a human digestive tract. As a person ingests food, thefood enters the mouth 100, is chewed, and then proceeds down theesophagus 101 to the lower esophageal sphincter at the gastroesophagealjunction 102 and into the stomach 103. The food mixes with enzymes inthe mouth 100 and in the stomach 103. The stomach 103 converts the foodto a semi-fluid substance called chyme. The chyme enters the pyloricantrum 104 and exits the stomach 103 through the pylorus 106 and pyloricorifice 105. The small intestine is about 21 feet long in adults. Thesmall intestine is comprised of three sections: the duodenum 112,jejunum 113 and ileum (not shown). The duodenum 112 is the first portionof the small intestine and is typically 10-12 inches long. The duodenum112 is comprised of four sections: the superior, descending, horizontaland ascending. The duodenum 112 ends at the ligament of Treitz 109. Thepapilla of Vater 108 is the duct that delivers bile and pancreaticenzymes to the duodenum 112. The duodenal bulb 107 is the portion of theduodenum which is closest to the stomach 103. As shown, an intestinalbypass sleeve 111 is implanted in the duodenum from the pyloric antrum104 and pylorus 106 to the ligament of Treitz 109. The intestinal bypasssleeve 111 is held in place at the pylorus 106 by an expandable anchor110 that anchors on the pylorus 106.

In various exemplary embodiments, the sleeve 111 is integrally formedwith or coupled to the expandable anchor 110. According to otherexemplary embodiments, the sleeve 111 is removably or releasably coupledto the expandable anchor 110. According to various embodiments, thebypass sleeve has a diameter of between about 10 mm and about 35 mm.According to various embodiments, the bypass sleeve has a thickness ofbetween about 0.001 and about 0.015 inches. Exemplary structures forremovably or releasably coupling or attaching the sleeve 111 to theexpandable anchor 110 are disclosed for example in U.S. patentapplication Ser. No. 12/752,697, filed Apr. 1, 2010, entitled “ModularGastrointestinal Prostheses,” which is incorporated herein by reference.According to various embodiments, the sleeve 111 or the expandableanchor 110 (or both) are further coupled at the pylorus 106 using one ormore of the techniques described in either of U.S. patent applicationSer. No. 12/752,697 or U.S. patent application Ser. No. 12/833,605,filed Jul. 9, 2010, entitled “External Anchoring Configuration forModular Gastrointestinal Prostheses,” both of which are incorporatedherein by reference. According to various embodiments of the invention,the sleeve 111 may be configured and coupled to the expandable anchor110, using one or more of the configurations disclosed in U.S. patentapplication Ser. No. 12/986,268, filed Jan. 7, 2011, entitled“Gastrointestinal Prostheses Having Partial Bypass Configurations,”which is incorporated herein by reference.

FIG. 2 is a sectional view of a portion of the digestive tract in ahuman body. As shown, an endoscope 114 has been inserted through: themouth 100, esophagus 101, stomach 103 and pyloric antrum 104 to allowvisualization of the pylorus 106. Endoscopes 114 are used for diagnosticand therapeutic procedures in the gastrointestinal tract. The typicalendoscope 114 is steerable by turning two rotary dials 115 to causedeflection of the working end 116 of the endoscope. The working end ofthe endoscope or distal end 116, typically contains two fiber bundlesfor lighting 117, a fiber bundle for imaging 118 (viewing) and a workingchannel 119. The working channel 119 can also be accessed on theproximal end of the endoscope. The light fiber bundles and the imagefiber bundles are plugged into a console at the plug in connector 120.The typical endoscope has a working channel in the 2.6 to 3.2 mmdiameter range. The outside diameter is typically in the 8 to 12 mmdiameter range depending on whether the endoscope is for diagnostic ortherapeutic purposes.

FIG. 3 is a drawing of an expandable anchor 110. The expandable anchor110 provides for an anchoring means to hold an intestinal bypass sleeve111 within the small intestine. In exemplary embodiments, the expandableanchor 110 is designed to allow the anchor to be of a self-expandingdesign. A self-expanding anchor design can be compressed in diameter toallow the device to be compressed in diameter to be loaded onto adelivery catheter. The anchor 110 can then recover elastically to theoriginal starting diameter, with the anchor diameter decreasing only asmall amount due to nonelastic recovery. The anchor 110 can also be madeof a plastically deformable design and require a mechanical forceapplied to it in the radial or longitudinal direction to accomplish theexpansion of the anchor. The mechanical force can be accomplished withan inflatable balloon type device, radially expanding the anchor 110, orit may also be accomplished by a longitudinal compression of the anchor110 by a screw type mechanism or cable tensioning means. As shown, theanchor 110 has a proximal portion or proximal disk 144 that is comprisedof 26 spring arms.

As shown, the anchor 110 has a distal portion (e.g., open-endedcylindrical portion) 143 that is comprised of 26 spring arms. Accordingto various embodiments, the anchor 110 could have from 3 to 72 springarms for the proximal disk and the open ended cylinder.

According to exemplary embodiments, the expandable anchor 110 is madefrom a nickel titanium alloys (Nitinol). Other alternative suitablealloys for manufacturing the anchor 110 are stainless steel alloys: 304,316L, BioDur® 108 Alloy, Pyromet Alloy® CTX-909, Pyromet® Alloy CTX-3,Pyromet®Alloy 31, Pyromet® Alloy CTX-1, 21Cr-6Ni-9Mn Stainless, Pyromet®Alloy 350, 18Cr-2Ni-12Mn Stainless, Custom 630 (17Cr-4Ni) Stainless,Custom 465® Stainless, Custom 455® Stainless, Custom 450® Stainless,Carpenter 13-8 Stainless, Type 440C Stainless, cobalt chromiumalloys—MP35N, Elgiloy, L605, Biodur® Carpenter CCM alloy, titanium andtitanium alloys, Ti-6Al-4V/ELI and Ti-6Al-7Nb, Ti-15Mo, Tantalum,Tungsten and tungsten alloys, pure platinum, platinum-iridium alloys,platinum-nickel alloys, niobium, iridium, conichrome, gold and goldalloys. The anchor 110 may also be comprised of the following absorbablemetals: pure iron and magnesium alloys. The anchor 110 may also becomprised of the following plastics: Polyetheretherketone (PEEK),polycarbonate, polyolefins, polyethylenes, polyether block amides(PEBAX), nylon 6, 6-6, 12, Polypropylene, polyesters, polyurethanes,polytetrafluoroethylene (PTFE) Poly(phenylene sulfide) (PPS),poly(butylene terephthalate) PBT, polysulfone, polyamide, polyimide,poly(p-phenylene oxide) PPO, acrylonitrile butadiene styrene (ABS),Polystyrene, Poly(methyl methacrylate) (PMMA), Polyoxymethylene (POM),Ethylene vinyl acetate, Styrene acrylonitrile resin, Polybutylene. Theanchor 110 may also be comprised of the following absorbable polymeres:Polyglycolic acid (PGA), Polylactide (PLA), Poly(ε-caprolactone),Poly(dioxanone) Poly(lactide-co-glycolide).

The anchor 110, according to exemplary embodiments, is laser cut from around tubing or from a flat sheet of Nitinol and then is rolled into acylindrical shape after laser cutting. The anchor 110, according toexemplary embodiments, is made from a Nitinol tube of about 9 mm outsidediameter by a wall thickness of 0.006 inch thick. Alternatively astarting tube outside diameter can range from about 2 mm to 16 mm. Analternative construction method is to laser cut or chemical etch thepattern from a flat sheet of Nitinol with a thickness of 0.002 inch to0.020 inch.

According to various embodiment, anchor 110 has an inside diameter 139in the range of about 2 mm to 20 mm. Anchor 110 has an expanded open end137 in the range of about 12 mm to 60 mm. Anchor 110 has a disk-shapedfeature 144 that has a diameter 145 in the range of about 12 mm to 60mm. Anchor 110 has a central cylinder 138 that has an outside diameterin the range of 4 mm to 20 mm. Anchor 110 has a flange 141 adjacent tothe large diameter open end that has a length of about 8 mm in length.According to various embodiments, this length 141 could range from alength of about 1 mm to 30 mm in length. Central cylinder section 138can have a length 140 of about 1 mm to 30 mm and is close to the widthof the pylorus 106. The proximal disk can have a length of 1 mm to 20mm. The proximal disk 144 can alternatively be formed in the shape of asphere. The central cylinder 138, in various embodiments, is made from amaterial having a stiffness sufficient to resist compressive forcesapplied by the pylorus.

FIG. 4 is a sectional view of the pyloric antrum 104, pyloric aperture105, pylorus 106, duodenal bulb 107 and duodenum 112. An expandableanchor 110 and intestinal bypass sleeve 111 are implanted into thepylorus 106. The expandable anchor 110 is shown here without a coveringmaterial to allow for better visualization of the expandable anchor 110.In various exemplary embodiments, the expandable anchor 110 is notcovered, while in other exemplary embodiments, it is covered with apolymer membrane made from a material such as silicone, flourosiliconeelastomers such as Viton, polyurethane, PTFE (polytetrafluoroethylene),FEP (fluorinated ethylene propylene), polyethylene, ePTFE (expandedpolytetrafluoroethylene), PFA (Perfluoroalkoxy), PVDF (PolyvinylideneFlouride, Tetrafluoroethylene), THV (Hexafluoropropylene and VinylideneFluoride), ETFE (Ethylenetetrafluoroethylene), ECTFE (Chloro TrifluoroEthylene/Ethylene Copolymer) EFEP (copolymer of ethylene,tetrafluoroethylene, and hexafluoropropylene), PVF (polyvinyl fluoride)or other suitable material. FIG. 16, for example, shows an embodiment ofthe expandable anchor 110 covered with a polymer film. The expandableanchor 110 can be made from metal or plastic. The intestinal bypasssleeve 111 can vary in length from 1-2 inches in length up to severalfeet. In some embodiments, the sleeve bypasses the length of theduodenum up to the ligament of Treitz. The sleeve can be longer andbypass into the jejunum. The intestinal bypass sleeve 111 may be madefrom a thin-walled polymer material such as silicone, flourosiliconeelastomers such as Viton, polyurethane, PTFE (polytetrafluoroethylene),FEP (fluorinated ethylene propylene), polyethylene, expandedpolytetrafluoroethylene (ePTFE), PFA (Perfluoroalkoxy), PVDF(Polyvinylidene Flouride, Tetrafluoroethylene), THV (Hexafluoropropyleneand Vinylidene Fluoride), ETFE (Ethylenetetrafluoroethylene), ECTFE(Chloro Trifluoro Ethylene/Ethylene Copolymer) EFEP (copolymer ofethylene, tetrafluoroethylene, and hexafluoropropylene), PVF (polyvinylfluoride) or other suitable material or combinations of the listedmaterials. In exemplary embodiments, the wall thickness of theintestinal bypass sleeve 111 maybe in the range of 0.001 inch to 0.012inch thick. The intestinal bypass sleeve 111 may be made by extrusion,into a tubular form or a lay flat tubing, dip coated from a liquidsolution, powder coated from fine particles of polymer or paste extrudedand then stretched as is the case with ePTFE.

Tantalum radiopaque markers 361 are attached to the intestinal bypass111 by encapsulation in a polymer 362 such as FEP. The radiopaquemarkers 361 can be attached to the intestinal bypass sleeve at fixedincrements along the length of the bypass sleeve 111 to allowvisualization of the sleeve during deployment and at patient follow-upto confirm the position of the bypass sleeve. The radiopaque markers 361can be made of disc of tantalum. A tantalum ball bearing or sphere canbe flattened to provide such a disk.

FIG. 5 is a drawing of an alternative embodiment of the invention hereindisclosed. The expandable anchor is comprised of a hollow tubularbraided structure of wire. The tubular braid can be braided in thediameter range from 10 mm in diameter up to about 70 mm in diameter. Thewire diameter can range from 0.001 inch to 0.014 inch. In exemplaryembodiments, the number of wire ends in the braid is 96 ends, but it canrange from as few as 4 ends up to 256 ends. The wire can be made from ametal such as Nitinol, MP35N, L605, Elgiloy, stainless steel or from aplastic such as PET, PEEK or Delrin or other suitable material. Thetubular wire braid is formed into a shape with a disk 360, a centralcylinder portion 363 and a cylindrical portion 359. Wire ends aregathered into bunches 361 and welded together or a sleeve is crimpedonto wires to keep the braided ends from fraying and unraveling.Alternatively, the structure could be made from a braid using a singlewire end. Central cylinder 363 has a through lumen 362 that allows chymeto flow from the stomach to the duodenum. The central cylinder 363 canbe rigid to hold the pylorus 106 open or it may be compliant to allowthe opening and closure through lumen 362 with the pylorus 106.

The length 364 of the device is typically about 50 mm but can range fromabout 10 mm to 100 mm. The diameter of the cylindrical portion 359 istypically about 25 mm in diameter, but can range from 10 mm to 75 mm.The diameter of the central cylinder portion is typically about 10 mm indiameter but can range from 2 mm up to 25 mm in diameter. The length ofthe central cylinder 363 is approximately that of the width of thepylorus 106, but the central cylinder 363 can be slightly longer toprovide a gap between central cylinder and pylorus or slightly shorterto provide for a compressive force to be applied to the pylorus. Theexpandable anchor is compressible in diameter and the diameter can bereduced to about 5 mm to 10 mm in diameter typically to allow the anchorto be loaded into a catheter. The expandable anchor can be covered onthe outside and/or inside side with a polymer membrane covering. Themembrane 365 covering the expandable anchor may be made from athin-walled polymer material such as silicone, polyurethane,polytetrafluoroethylene (PTFE), fluorinated ethylene propylene,polyethylene, expanded polytetrafluoroethylene (ePTFE) or other suitablematerial. In some embodiments, the wall thickness of the membranecovering the expandable anchor may be in the range of 0.001 inch to0.030 inch thick. The membrane 365 may be made by extrusion, dip coatingfrom a liquid solution, powder coated from fine particles of polymer orpaste extruded and then stretched as is the case with ePTFE. Theexpandable anchor membrane 365 may also be cut from a flat sheet ofmaterial such as ePTFE and then bonded or sewn into a disk shape orspherical shaped structure and then attached to the expandable anchor bysewing or gluing with a polymer such as FEP.

FIG. 6 is a sectional view of the invention herein disclosed in FIG. 5implanted into the pyloric antrum 104, pylorus 106, duodenal bulb 107,and duodenum 112. An intestinal bypass sleeve 111 is attached to theanchor.

FIG. 7 is a drawing of an alternative embodiment of an expandableanchor. The expandable anchor provides for an anchoring means to hold anintestinal bypass sleeve 111 within the small intestine. The expandableanchor is comprised of two toroidally shaped wound springs 600 connectedto a central cylinder 601 by control arms 602. The toroidal springs 600are prewound in a straight configuration and then the springs 600 arewound through the eyelets 604 on the end of the control arms and formedinto the toroidal shape. The expandable anchor can be non-covered or itcan have a polymer covering on the outside and inside as disclosed inFIG. 16. The spring ends are joined together at a spring joiner 614. Thespring ends may be fastened to the spring joiner 614 by mechanical meansor they may be laser welded to the spring joiner 614. The spring joinerserves two purposes, to provide for a means of spring end terminationand joining of the two spring ends and also provides for an exit pointfor the drawstring 605 to exit the spring 600. The drawstring 605 is fedthrough the central axis of the toroidal spring 600. A drawstring 605may be used only on the proximal disk or on both the proximal and distaldisks.

The two ends of the drawstring 605 both exit the spring joiner 614 andare terminated at ball 606. Pulling on the ball 606 and drawing thedrawstring 605 through the spring joiner 614 causes the diameter of thespring 600 to be reduced and the control arms to bend and deflect asshown in FIG. 15. The drawstring 605 can also be terminated in loop 607or with two balls 608 spaced apart.

The toroidal springs are further disclosed in FIG. 12 and FIG. 13. Thecentral cylinder and the control arms of the exemplary embodiment arelaser cut from a piece of Nitinol tubing. In the exemplary embodiments,the expandable anchor is designed to allow the anchor to be of aself-expanding design. A self-expanding anchor design can be compressedin diameter to allow the device to be loaded onto a delivery catheter.The anchor can then recover elastically to the original startingdiameter, with the anchor diameter decreasing only a small amount due tononelastic recovery. The anchor can also be made of a plasticallydeformable design and require a mechanical force applied to it in theradial or longitudinal direction to accomplish the expansion of theanchor. The mechanical force can be accomplished with an inflatableballoon type device, radially expanding the anchor or it may also beaccomplished by a longitudinal compression of the anchor by a screw typemechanism or cable tensioning means. As shown, the anchor has a distaldisk and a proximal disk that is comprised of 14 control arms on eachportion. According to various embodiments, the anchor could have from 3to 72 control arms for the proximal disk and the distal disk.

According to exemplary embodiments, the central cylinder 601 and controlarms 602 are made from a nickel titanium alloy (Nitinol). Springs 600are made from MP35N LT. Other alternative suitable alloys formanufacturing the central cylinder 601, control arms 602 and springs 600are stainless steel alloys: 304, 316L, BioDur®108 Alloy, Pyromet Alloy®CTX-909, Pyromet® Alloy CTX-3, Pyromet® Alloy 31, Pyromet® Alloy CTX-1,21 Cr-6Ni-9Mn Stainless, Pyromet Alloy 350, 18Cr-2Ni-12Mn Stainless,Custom 630 (17Cr-4Ni) Stainless, Custom 465®Stainless, Custom 455®Stainless, Custom 450® Stainless, Carpenter 13-8 Stainless, Type 440CStainless, cobalt chromium alloys-MP35N, Elgiloy, L605, Biodur®Carpenter CCM alloy, titanium and titanium alloys, Ti-6Al-4V/ELI andTi-6Al-7Nb, Ti-15Mo, Tantalum, Tungsten and tungsten alloys, pureplatinum, platinum-iridium alloys, platinum-nickel alloys, niobium,iridium, conichrome, gold and gold alloys. The anchor may also becomprised of the following absorbable metals: pure Iron and magnesiumalloys. The central cylinder 601, control arms 602 and springs 600 mayalso be comprised of the following plastics: Polyetheretherketone(PEEK), polycarbonate, polyolefins, polyethylenes, polyether blockamides (PEBAX), nylon 6, 6-6, 12, Polypropylene, polyesters,polyurethanes, polytetrafluoroethylene (PTFE) Poly(phenylene sulfide)(PPS), poly(butylene terephthalate) PBT, polysulfone, polyamide,polyimide, poly(p-phenylene oxide) PPO, acrylonitrile butadiene styrene(ABS), Polystyrene, Poly(methyl methacrylate) (PMMA), Polyoxymethylene(POM), Ethylene vinyl acetate, Styrene acrylonitrile resin,Polybutylene. The anchor, according to exemplary embodiments, is lasercut from a round tubing or from a flat sheet of Nitinol and then isrolled into a cylindrical shape after laser cutting. The anchor,according to exemplary embodiments, is made from a Nitinol tube of about9 mm outside diameter by a wall thickness of 0.012 inch thick.Alternatively a starting tube outside diameter can range from about 2 mmto 16 mm. An alternative construction method is to laser cut or chemicaletch the pattern from a flat sheet of Nitinol with a thickness of 0.002inch to 0.020 inch.

According to various embodiments, the anchor has an inside diameter 610in the range of about 2 mm to 20 mm. The anchor has disk-shaped featuresthat have a diameter 609 in the range of about 20 mm to 66 mm. Anchorhas a central cylinder 601 that has an outside diameter in the range of4 mm to 20 mm. Central cylinder section 601 can have a length 612 ofabout 1 mm to 30 mm and is close to width of the pylorus 106. The diskscan have a length 611 of 1 mm to 10 mm. The proximal disk and distaldisk can alternatively be formed in the shape of a cup. The centralcylinder 601, in various embodiments, is made from a material having astiffness sufficient to resist compressive forces applied by thepylorus. The control arms 602 can radially project out through thediameter of the spring 600 and form a barb 613 on the outside diameterof the spring 600.

FIG. 8 is a drawing of a flat representation of the circumference of thecentral cylinder 601 and control arms 602. The control arms have roundholes at the end of the arms to wind the toroidal spring through whenassembling the springs 600 onto the control arms 602 to make anexpandable anchor. The holes 604 at the end of the control arms 602 canbe made in an alternative shape such as elliptical, rectangular orsquare. Alternatively the control arms 602 may have an open slot 615 toallow the spring to be snap fit into the opening on the control arms602. The end of the control arms 602 may also have a t-shape that couldbe inserted into a slot 760 laser cut into the wire of the spring 600.The two edges of the flat representation 616 and 617 will touch when theflat representation is wrapped around a cylinder.

FIG. 9 is a drawing of a heat set mandrel 616 used to heat set the lasercut Nitinol tube shown in FIG. 8 into the final shape of the centralcylinder 601 and control arms 602 of FIG. 10. The inside diameter 617 ofthe heat set mandrel 616 closely approximates the outside diameter ofthe central cylinder 601. A radius 618 is cut into the mandrel to forcethe Nitinol to bend to a gradual radius to control the strain levelduring shape setting of the Nitinol part into the final shape of FIG.10. Laser cut tube of FIG. 8 is inserted into the heat set mandrel ofFIG. 9. The control arms are bend outward and then compressedlongitudinally to the final location 619 on the heat set mandrel. TheNitinol laser cut tube and the heat set mandrel 616 are then heated to atemperature of 500 degree centigrade for 10 minutes and then quicklycooled to room temperature. The laser cut tube is then removed from theinside of the heat set mandrel 616 and the laser cut tube is now set tothe shape in FIG. 10.

FIG. 10 is a drawing of the laser cut tube of FIG. 8. After it has beenheat set and formed into the final shape for the expandable anchor.Control arms 602 are formed radially outward from the central cylinder601. The bend angle 620 of the control arms can be from −30 degrees toapproximately 45 degrees.

FIG. 11 is a drawing of an alternative embodiment of a central cylinderand control arms. The control arms are attached to the central cylinderby a simple pin 622 and socket 623 arrangement like used in four barlinkages. The number of arms control arms can range from 3 to 72.

FIG. 12 is a drawing of toroidal shaped spring 600 as used in theexpandable anchor of FIG. 7. The toroidal spring 600 is shown separatelyhere for ease of illustration, but the spring 600 will be assembled ontothe control arms 602 to form an expandable anchor as in FIG. 7.

The toroidal-shaped spring 600 may be first formed by winding a straightcompression spring 600. The compression spring 600 may be made fromround wire 286, rectangular wire 287, square wire 288, or ellipticalwire 289. The compression spring 600 can be wound to have a round shape290, rectangular shape 291, square shape 292, or an elliptical shape293. The wire may be made from Nitinol, stainless steel, Elgiloy, L605,MP35N titanium, niobium or other suitable metal. The wire is, in variousembodiments, made of a solid wire but can alternatively be made ofstranded or braided wire. The outer diameter or inner core of the wiremay be clad or plated with gold, tantalum, platinum, iridium, or othersuitable material. The wire may be co-drawn (e.g., drawn filledtube-Fort Wayne Metals) and have an outer core of a high strengthmaterial such as Nitinol, stainless steel, Elgiloy, L605, MP35N,titanium, niobium and an inner core of a high radio-opacity materialsuch as gold, tantalum, platinum, or iridium. Alternatively, the wire ismade from a plastic monofilament such as PEEK, PET or Delrin.Compression spring 624 is formed into a toroidal shape by bending springends towards each other and winding the spring through the holes 604 inthe ends of the control arms 602 and joining spring ends at springjoiner connector 614. A perspective view of the toroidal spring is shownin 625 (not assembled to control arms 602). A drawstring 605 iscontained within the center of the toroidal spring 600. The drawstring605 is threaded through a hole in the spring joiner 614. Drawstring 605is terminated at spheres that can be crimped onto the end of thedrawstring 605. The spheres may be made of metal or plastic and may beattached to the drawstring 605 by crimping, welding, gluing, insertmolding or other suitable means. The drawstring may be comprised ofplastic or metal and may be made of a monofilament or braided cablematerial. When spheres 605 are withdrawn from spring joiner 614,drawstring 605 is tensioned and the diameter of the toroidal spring andcontrol arms 602 is reduced to the smaller diameter as in 285.

FIG. 13A is a drawing of an alternative embodiment of an expandableanchor formed in the shape of a toroidal-shaped spring 282 as previouslydisclosed in FIG. 12. The spring may have small tissue penetratinganchors 296 on the outer surface of the spring. Tissue penetratinganchor 296 may be made from, stainless steel, Elgiloy, L605, MP35N,titanium or niobium and may be crimped onto the wire or welded. Tissuepenetrating anchors 296 may be an optional feature that can be added ifthe patient's anatomy does not have a pyloric ring that is adequate foranchoring.

FIG. 13B is a drawing of an alternative embodiment of an expandableanchor formed in the shape of a toroidal-shaped spring as previouslydisclosed in FIG. 12. The toroidal-shaped spring is formed of segmentswhere the direction of the winding of the spring is reversed to cancelout the helical twisting action of the spring. The individual segments297, 298, 299 and 300 can be connected at joiners 301. Alternatively theentire toroidal spring can be laser cut as one unitary piece by lasercutting the wound coil in the unformed shape as in 281 from a piece ofround tubing.

FIG. 13C is a drawing of an alternative embodiment of an expandableanchor formed in the shape of a toroidal-shaped spring as previouslydisclosed in FIG. 12. The spring is wound to have double helices thatare 180 degrees offset from each other.

FIG. 14 is a drawing (a flat representation of the circumference) of analternative embodiment of the central cylinder 601 and control arms 602for an expandable anchor as disclosed in FIG. 7. The central cylinder601 has slots 626 cut into the wall of the tubing. The slots 626 canelastically elongate and compress circumferentially as in 627 to allowthe diameter of the central tube to be compressed to be loaded onto adelivery catheter and then elastically rebound to the original largerdiameter when the expandable anchor is deployed through the deliverycatheter. The control arms 602 have round holes 604 at the end of thearms to wind the toroidal spring through when assembling the springs 600onto the control arms 602 to make an expandable anchor. The two edges ofthe flat representation 616 and 617 will touch when the flatrepresentation is wrapped around a cylinder.

FIG. 15 is a drawing of an expandable anchor and an intestinal bypasssleeve 111. Expandable anchor can be reduced in diameter by applyingtension to the drawstring at the balls 608. The diameter of the toroidalspring 600 decreases and the control arms 602 rotate from 628 to 630 asthe diameter of the toroidal springs are decreased in size.

FIG. 16 is a sectional view of the pyloric antrum 104, pyloric aperture105, pylorus 106, duodenal bulb 107 and duodenum 112. An expandableanchor 633 and intestinal bypass sleeve 111 is implanted into thepylorus 106. The expandable anchor 633 is shown here in cross section toallow for better visualization of the polymer covering on the expandableanchor 633. The expandable anchor 633 is encapsulated on the outside andinside with a polymer covering 634.

In various exemplary embodiments, the expandable anchor 633 is notcovered, while in other exemplary embodiments, it is covered with apolymer membrane made from a material such as silicone, flourosiliconeelastomers such as Viton, polyurethane, PTFE (polytetrafluoroethylene),FEP (fluorinated ethylene propylene), polyethylene, ePTFE (expandedpolytetrafluoroethylene), PFA (Perfluoroalkoxy), PVDF (PolyvinylideneFlouride, Tetrafluoroethylene), THV (Hexafluoropropylene and VinylideneFluoride), ETFE (Ethylenetetrafluoroethylene), ECTFE (Chloro TrifluoroEthylene/Ethylene Copolymer) EFEP (copolymer of ethylene,tetrafluoroethylene, and hexafluoropropylene), PVF (polyvinyl fluoride).The expandable anchor 633 can be made from metal or plastic. Theintestinal bypass sleeve 111 can vary in length from 1-2 inches inlength up to several feet. In some embodiments, the sleeve bypasses thelength of the duodenum up to the ligament of Treitz. The sleeve can belonger and bypass into the jejunum. The intestinal bypass sleeve 111 maybe made from a thin-walled polymer material such as silicone,flourosilicone elastomers such as Viton, polyurethane, PTFE(polytetrafluoroethylene), FEP (fluorinated ethylene propylene),polyethylene, expanded polytetrafluoroethylene (ePTFE), PFA(Perfluoroalkoxy), PVDF (Polyvinylidene Flouride, Tetrafluoroethylene),THV (Hexafluoropropylene and Vinylidene Fluoride), ETFE(Ethylenetetrafluoroethylene), ECTFE (Chloro Trifluoro Ethylene/EthyleneCopolymer) EFEP (copolymer of ethylene, tetrafluoroethylene, andhexafluoropropylene), PVF (polyvinyl fluoride) or other suitablematerial or combinations of the listed a materials. The ePTFE materialmay be coated with another polymer material such as silicone, FEP orother suitable material to render it totally impermeable. In exemplaryembodiments, the wall thickness of the intestinal bypass sleeve 111maybe in the range of 0.001 inch to 0.012 inch thick. The intestinalbypass sleeve 111 may be made by extrusion, into a tubular form or a layflat tubing, dip coated from a liquid solution, powder coated from fineparticles of polymer or paste extruded and then stretched as is the casewith ePTFE. Intestinal bypass sleeve may be made porous or nonporous.Sleeve may have surface coatings to close up pores of porous membrane.Such as a surface coating of silicone, polyurethane, FEP applied toporous substrate to render it non-permeable. ePTFE is inherentlyhydrophobic and has some resistance to water penetration, but it may bedesirable to have a higher water entry pressure or make ePTFEimpermeable. Intestinal bypass sleeve may have a lubricious (or sticky)hydrophilic coating or a hydrogel added to the inner or outer surface toreduce the friction of the surface or to make it easier for food to passthrough the liner or to decrease the outer surface coefficient offriction or make the sleeve stay in place better in the intestines.Intestinal bypass sleeve or expandable anchor may be used for drugdelivery, delivery of peptides or other therapeutics by incorporating adrug or peptide into the polymer wall thickness of the intestinal bypasssleeve. The drug or peptide may be added directly to the surface of theintestinal liner without a polymer or covalently bonded to the polymersurface.

The drug or peptide may be eluted from a surface coating on the sleeveor anchor which incorporates the drug into the coating. Polymers thatmay be used as a coating to elute a drug include silicone, polyurethane,Polyvinyl Alcohol, Ethylene vinyl acetate, Styrene acrylonitrile,Styrene-Butadiene, Pebax® or other suitable polymer. Absorbable polymersthat may be used for drug delivery include, Polyglycolic acid (PGA),Polylactide (PLA), Poly(ε-caprolactone), Poly(dioxanone)Poly(lactide-co-glycolide) or other suitable polymer. Other suitablecoatings for increased biocompatibility or drug release may includehuman amnion, collagen Type I, II, III, IV, V, VI—Bovine, porcine, orovine. The coating on the intestinal bypass sleeve can also take theform of a liquid that can be used to release the drug or peptideinclude, Vitamin D, A, C, B, E, olive oil, polyethylene glycol,vegetable oils, essential fatty acids, alpha-linolenic acid, lauricacid, linoleic acid, gamma-linolenic acid, palmitoleic acid or othersuitable liquids. The drug may serve to increase satiety, to interruptthe secretion of secondary hormones or digestive enzymes, releaseantibacterial agents to reduce infection, to increase the fibroticreaction of the intestinal tract, to decrease the fibrotic reaction ofthe intestinal tract, to target changes in the cellular composition suchas decreasing the number of receptor cells in the duodenum.

Intestinal bypass sleeve can release cholecystokinin, gastrin, secretin,gastric inhibitory peptide, motilin, glucagon like peptide 1, bile,insulin, pancreatic enzymes, ghrelin, penicillin, amoxicillin,ampicillin, carbenicillin, cloxacillin, dicloxacillin, nafcillin,oxacillin, penicillin g, penicillin V, Piperacillin, TicarcillinAminoglycosides, Amikacin, Gentamicin, Kanamycin, Neomycin, NEO-RX,Netilmicin, Streptomycin, Tobramycin, Carbapenems, Ertapenem, Doripenem,DORIBAX, Emipenem-cilastatin, Meropenem, Cefadroxil, Cefazolin,Cephalexin rapymicin, taxol, Vitamin A, Vitamin C, Vitamin D, Vitamin B,Vitamin E, fatty acids, oils, vegetable oils, aspirin, somastatin,motilin, trypsinogen, chymotrypsinogen, elastase, carboxypeptidase,pancreatic lipase, amylase, enteroglucagon, gastric inhibitorypolypeptide, Vasoactive intestinal peptide, PYY, Peptide TyrosineTyrosine, Leptin, Pancreatic polypeptide.

FIG. 17 is a drawing of the expandable anchor as shown in FIG. 16wherein the expandable anchor 633 is deployed/placed into the duodenalbulb 107 instead of across the pylorus 106. Other alternative implantlocations include the duodenum 112, pyloric antrum 104 and thegastroesophageal (GE) junction.

FIG. 18 is a drawing of a flat representation of an alternate embodimentof the circumference of the laser cut central cylinder 601 and controlarms 602. The control arms have round holes 604 at the end of the armsto wind the toroidal shape spring through when assembling the springs600 onto the control arms 602 to make an expandable anchor. The twoedges of the flat representation of the circumference 616 and 617 willtouch when the flat representation is wrapped around a cylinder. Theexpanded final shape for the laser cut part disclosed in FIG. 18 willassume a shape similar to FIG. 23. An alternative embodiment of thefinal expandable anchor of FIG. 18 does not incorporate the toroidalwound spring 600 into the final expandable anchor.

FIG. 19 is a drawing of a flat representation of an alternate embodimentof the circumference of the laser cut central cylinder 601 and controlarms 602. The control arms have round holes 604 at the end of the armsto wind the toroidal shaped spring through when assembling the springs600 onto the control arms 602 to make an expandable anchor. The twoedges of the flat representation of the circumference 616 and 617 willtouch when the flat representation is wrapped around a cylinder. Theexpandable anchor of FIG. 19 incorporates an expandable and compressiblecentral cylinder by including slots cut into the circumference of thetube. This was previously disclosed in FIG. 14.

The expanded final shape for the laser cut part disclosed in FIG. 19will assume a shape similar to FIG. 23. An alternative embodiment of thefinal expandable anchor of FIG. 19 does not incorporate the toroidalwound spring 600 into the final expandable anchor.

FIG. 20 is a drawing of a flat representation of an alternate embodimentof the circumference of the laser cut central cylinder 601 and controlarms 602. The control arms have round holes 604 at the end of the armsto wind the toroidal shaped spring through when assembling the springs600 onto the control arms 602 to make an expandable anchor. The twoedges of the flat representation of the circumference 616 and 617 willtouch when the flat representation is wrapped around a cylinder. Theexpanded final shape for the laser cut part disclosed in FIG. 20 willassume a shape similar to FIG. 23. An alternative embodiment of thefinal expandable anchor of FIG. 20 does not incorporate the toroidalwound spring 600 into the final expandable anchor.

FIG. 21 is a drawing of an alternative embodiment of an expandableanchor. The expandable anchor provides for an anchoring means to hold anintestinal bypass sleeve 111 within the small intestine. The expandableanchor is comprised of two toroidally shaped wound springs 600 connectedto a central cylinder 601 by control arms 602. The toroidal springs 600are prewound in a straight configuration and then the springs 600 arewound through the eyelets 604 on the end of the control arms and formedinto the toroidal shape. The expandable anchor can be noncovered or itcan have a polymer covering on the outside and inside as disclosed inFIG. 16. The spring ends are joined together at a spring joiner 614(shown in FIG. 7). The spring ends may be fastened to the spring joiner614 by mechanical means or they may be laser welded to the spring joiner614. The spring joiner serves two purposes, to provide for a means ofspring end termination and joining of the two spring ends and alsoprovides for an exit point for the drawstring 605 to exit the spring600. The drawstring 605 (shown in FIG. 7) is fed through the centralaxis of the toroidal spring 600. The two ends of the drawstring 605 bothexit the spring joiner 614 and are terminated at ball 606. Pulling onthe ball 606 and drawing the drawstring 605 through the spring joiner614 causes the diameter of the spring 600 to be reduced and the controlarms to bend and deflect as shown in FIG. 15. The drawstring 605 canalso be terminated in loop 607 or with two balls spaced apart 608.

The toroidal springs are further disclosed in FIG. 12 and FIG. 13. Thecentral cylinder and the control arms of the exemplary embodiment arelaser cut from a piece of Nitinol tubing. In the exemplary embodiments,the expandable anchor is designed to allow the anchor to be of aself-expanding design. A self-expanding anchor design can be compressedin diameter to allow the device to be compressed in diameter to beloaded onto a delivery catheter. The anchor can then recover elasticallyto the original starting diameter, with the anchor diameter decreasingonly a small amount due to nonelastic recovery. The anchor can also bemade of a plastically deformable design and require a mechanical forceapplied to it in the radial or longitudinal direction to accomplish theexpansion of the anchor. The mechanical force can be accomplished withan inflatable balloon type device, radially expanding the anchor or itmay also be accomplished by a longitudinal compression of the anchor bya screw type mechanism or cable tensioning means. As shown, the anchorhas a distal disk and a proximal disk that is comprised of 14 controlarms on each portion. According to various embodiments, the anchor couldhave from 3 to 72 control arms for the proximal disk and the distaldisk.

According to exemplary embodiments, the central cylinder 601, controlarms 602 and springs 600 are made from a nickel titanium alloy(Nitinol). Other alternative suitable alloys for manufacturing thecentral cylinder 601, control arms 602 and springs 600 are stainlesssteel alloys: 304, 316L, BioDur® 108 Alloy, Pyromet Alloy® CTX-909,Pyromet® Alloy CTX-3, Pyromet® Alloy 31, Pyromet® Alloy CTX-1, 21Cr-6Ni-9Mn Stainless, Pyromet Alloy 350, 18Cr-2Ni-12Mn Stainless, Custom630 (17Cr-4Ni) Stainless, Custom 465® Stainless, Custom 455® Stainless,Custom 450® Stainless, Carpenter 13-8 Stainless, Type 440C Stainless,cobalt chromium alloys—MP35N, Elgiloy, L605, Biodur®Carpenter CCM alloy,Titanium and titanium alloys, Ti-6Al-4V/ELI and Ti-6Al-7Nb, Ti-15Mo,Tantalum, Tungsten and tungsten alloys, pure platinum, platinum-iridiumalloys, platinum-nickel alloys, niobium, iridium, conichrome, gold andgold alloys. The anchor 110 may also be comprised of the followingabsorbable metals: pure iron and magnesium alloys. The central cylinder601, control arms 602 and springs 600 may also be comprised of thefollowing plastics: Polyetheretherketone (PEEK), polycarbonate,polyolefins, polyethylenes, polyether block amides (PEBAX), nylon 6,6-6, 12, Polypropylene, polyesters, polyurethanes,polytetrafluoroethylene (PTFE) Poly(phenylene sulfide) (PPS),poly(butylene terephthalate) PBT, polysulfone, polyamide, polyimide,poly(p-phenylene oxide) PPO, acrylonitrile butadiene styrene (ABS),Polystyrene, Poly(methyl methacrylate) (PMMA), Polyoxymethylene (POM),Ethylene vinyl acetate, Styrene acrylonitrile resin, Polybutylene. Theanchor, according to exemplary embodiments, is laser cut from a roundtubing or from a flat sheet of Nitinol and then is rolled into acylindrical shape after laser cutting. The anchor, according toexemplary embodiments, is made from a Nitinol tube of about 9 mm outsidediameter by a wall thickness of 0.012 inch thick. Alternatively astarting tube is outside diameter can range from about 2 mm to 16 mm. Analternative construction method is to laser cut or chemical etch thepattern from a flat sheet of Nitinol with a thickness of 0.002 inch to0.020 inch.

According to various embodiments, the anchor has an inside diameter 610in the range of about 2 mm to 20 mm, anchor has a disk-shaped featureand a cup that has a diameter 609 in the range of about 20 mm to 66 mm.Anchor has a central cylinder 601 that has an outside diameter in therange of 4 mm to 20 mm. Central cylinder section 601 can have a length612 of about 1 mm to 30 mm and is close to the width of the pylorus 106.The disks can have a length 611 of 1 mm to 10 mm. The cup shape portioncan have a length of 1 mm to 50 mm. The central cylinder 601, in variousembodiments, is made from a material having a stiffness sufficient toresist compressive forces applied by the pylorus.

FIG. 22 is a drawing of an alternative embodiment of an expandableanchor. The expandable anchor provides for an anchoring means to hold anintestinal bypass sleeve 111 within the small intestine. The expandableanchor is comprised of two toroidally shaped wound springs 600 connectedto a central cylinder 601 by control arms 602. The toroidal springs 600are prewound in a straight configuration and then the springs 600 arewound through the eyelets 604 on the end of the control arms and formedinto the toroidal shape. The expandable anchor can be noncovered or itcan have a polymer covering on the outside and inside as disclosed inFIG. 16. The spring ends are joined together at a spring joiner 614(shown in FIG. 7). The spring ends may be fastened to the spring joiner614 by mechanical means or they may be laser welded to the spring joiner614. The spring joiner serves two purposes, to provide for a means ofspring end termination and joining of the two spring ends and alsoprovides for an exit point for the drawstring 605 to exit the spring600. The drawstring 605 (shown in FIG. 7) is fed through the centralaxis of the toroidal spring 600. The two ends of the drawstring 605 bothexit the spring joiner 614 and are terminated at ball 606 (shown in FIG.7). Pulling on the ball 606 and drawing the drawstring 605 through thespring joiner 614 causes the diameter of the spring 600 to be reducedand the control arms to bend and deflect as shown in FIG. 15. Thedrawstring 605 can also be terminated in loop 607 or with two ballsspaced apart 608.

According to various embodiments, anchor has an inside diameter 610 inthe range of about 2 mm to 20 mm, the anchor has two cup shaped featuresthat have a diameter 609 in the range of about 20 mm to 65 mm. The cupshape portions can have a length of 3 mm to 50 mm. Anchor has a centralcylinder 601 that has an outside diameter in the range of 4 to 20 mm.Central cylinder section 601 can have a length 612 of about 1 mm to 30mm and is close to the width of the pylorus 106. The cup shape portionscan have a length of 1 mm to 50 mm. The central cylinder 601, in variousembodiments, is made from a material having a stiffness sufficient toresist compressive forces applied by the pylorus. The materials andprocessing of FIG. 22 is identical to that disclosed previously in FIG.21.

FIG. 23 is a drawing of an alternative embodiment of an expandableanchor. The expandable anchor provides for an anchoring means to hold anintestinal bypass sleeve 111 within the small intestine. The expandableanchor is comprised of two toroidally shaped wound springs 600 connectedto a central cylinder 601 by control arms 602. The toroidal springs 600are prewound in a straight configuration and then the springs 600 arewound through the eyelets 604 on the end of the control arms and formedinto the toroidal shape. The expandable anchor can be noncovered or itcan have a polymer covering on the outside and inside as disclosed inFIG. 16. The spring ends are joined together at a spring joiner 614(shown in FIG. 7). The spring ends may be fastened to the spring joiner614 by mechanical means or they may be laser welded to the spring joiner614. The spring joiner serves two purposes, to provide for a means ofspring end termination and joining of the two spring ends, and alsoprovides for an exit point for the drawstring 605 to exit the spring600. The drawstring 605 (shown in FIG. 7) is fed through the centralaxis of the toroidal spring 600. The two ends of the drawstring 605 bothexit the spring joiner 614 and are terminated at ball 606 (shown in FIG.7). Pulling on the ball 606 and drawing the drawstring 605 through thespring joiner 614 causes the diameter of the spring 600 to be reducedand the control arms to bend and deflect as shown in FIG. 15. Thedrawstring 605 can also be terminated in loop 607 or with two ballsspaced apart 608.

According to various embodiments, the anchor has an inside diameter 610in the range of about 2 mm to 20 mm, the anchor has two cup shapedfeatures that have a diameter 609 in the range of about 20 mm to 65 mm.The cup shape portions can have a length of 3 mm to 50 mm. The anchorhas a central cylinder 601 that has an outside diameter in the range of4 mm to 20 mm. The central cylinder section 601 can have a length 612 ofabout 1 mm to 30 mm and is close to width of the pylorus 106. The cupshape portions can have a length of 1 mm to 50 mm. The central cylinder601, in various embodiments, is made from a material having a stiffnesssufficient to resist compressive forces applied by the pylorus. Thematerials and processing of FIG. 23 is identical to that disclosedpreviously in FIG. 21. Expandable anchor in FIG. 23 has control armswhich are joined at the outer end by connectors 634. The diamond shapepattern at connectors 634 opens and closes as the diameter of theexpandable anchor changes.

FIG. 24 is a drawing of an alternative embodiment of control arms 635.The control arms 635 are laser cut from a flat sheet of Nitinol. Thecontrol arms are joined together at a central ring 636. The control arms635 have holes 604 at the end of the arms. The diameter material andmaterials have been previously disclosed in FIG. 21.

FIG. 25 is a drawing of an alternative embodiment of a central cylinder601. The central cylinder 601 is made from a piece of metal or plastictubing. The central cylinder has an annular groove on the outsidediameter at each end to snap fit on the control arms from FIG. 25 intothe annular groove. The central cylinder can be machined or molded andcan be comprised of material previously disclosed in FIG. 7.

FIG. 26 is a drawing of an expandable anchor assembly. The assembly iscomprised of a control arm disk of FIG. 24, and a central cylinder ofFIG. 25, assembled together with two toroidal shape springs 600. Thecontrol arm disk central ring 636 is elastically expanded in diameterand then snapped into annular groove 637 on the central cylinder. Whenthe control arms 635 are bent towards the central cylinder 601, thecentral ring 636 rolls into the annular groove 637 and the central ringreverts and turns partially inside out as the control arms 635 deflect.

FIG. 27 is drawing of a central cylinder pyloric portion for use withany of the anchor embodiments herein disclosed in which the mid-portionallows for normal opening and closing of the pylorus. There is a firstring 333 and a second ring 334 which are fixed rigidly together byconnector links 335, 338 or 337. The central cylinder has an annulargroove 637 on the outside diameter of the cylinder as previouslydisclosed in FIG. 25.

The connector links cross through the pyloric aperture 105 while notobstructing the pyloric aperture 105 or limiting opening or closing ofthe pylorus. In various embodiments, a thin polymeric membrane will beused over both rings 333 and 334 and will span the space between the tworings as disclosed in FIG. 26. The pylorus 106 can close by enteringinto the space 339 in between rings 333 and 334 to open and close. Rigidlinking of rings 333 and 334 provides for a rigid structure to anchorexpandable anchors to and helps to keep expandable anchor (disks)oriented in the proper orientation without canting within the pyloricantrum 104 or duodenal bulb 107. The rigid linking also does not allowrotational movement between the two rings 333 and 334 and still allowsfor normal opening and closing of the pylorus. Rotational movementbetween 333 and 334 may cause the pyloric polymer membrane portion toclose. The expandable anchors in the pyloric antrum and the duodenalbulb are tethered to the first ring 333 and second ring 334 by a polymermembrane.

FIG. 28 is a sectional view of the invention herein disclosed implantedinto the pyloric antrum 104, pylorus 106, duodenal bulb 107 and duodenum112. The anchoring device is comprised of two disk-shaped expandableanchors 394 that are connected to a central cylinder 396 and 397.Alternatively the disk can be constructed from a disk and toroidalsprings as previously disclosed in FIG. 14 or FIG. 7. The centralcylinder of the device 396 and 397 in between the two anchor rings 394can be made from plastic material such as Delrin, PEEK, high densitypolyethylene, polycarbonate or other suitable polymer. The centralcylinder portion 396 and 397 may also be made from stainless steel,titanium or Nitinol. The fixed diameter of the pyloric portion pieces396 and 397 of the device can be sized to provide for a full opening ofthe pylorus and not allow the pylorus to close normally. The length ofthe pyloric portion of the device 400 can be adjusted by sliding theouter cylinder 396 over inner cylinder 397 by sliding on the ratchetingmechanism. This will change the spacing between the anchor rings 394 andwill allow the device to be adjusted for ring spacing in-situ. It may bedesirable to change the ring spacing to accommodate differences in thepylorus 106 dimensions from patient to patient. It may also be desirableto change the length 400 of the central cylinder portion to allow theanchor ring 394 spacing to be adjusted to allow the expandable anchor toput a clamping force on to the pylorus in a longitudinal direction. Themechanism used for 398 and 399 could also be a screw thread arrangementsuch as a male thread on 398 and a female thread on 399. In variousembodiments, the inside diameter of the central cylinder 396 and 397ranges from as small as 2 mm in diameter up to as large as 14 mm indiameter. The central lumen of the device has a one-way, anti-refluxvalve 401. The anti-reflux valve 401 allows for unobstructed flow in thedirection of the pyloric antrum 104 to the duodenal bulb 107, but limitsflow in the reverse direction. The anti-reflux valve 401 can beconstructed of a duck bill design with two flexible leaflets, or mayutilize other designs such as a tri-leaflet valve or quad-leaflet valve.The anti-reflux valve may be constructed of silicone, polyurethane,polyethylene, ePTFE or other suitable polymer. The diameter of thecentral cylinder is fixed, but it may also be designed to allow it to bereduced in diameter during loading of the device onto a catheter.

FIG. 29 is a sectional view of the invention herein disclosed implantedinto the pyloric antrum 104, pylorus 106 and duodenal bulb 107 andduodenum 112. The anchoring device is comprised of two toroidal-shapedexpandable anchors 402 that are connected to a central cylinder 403.Alternatively the disk can be constructed from a disk and toroidalsprings as previously disclosed in FIG. 14 or FIG. 7. The diameter ofthe central cylinder 403 is fixed, but it may also be elastic to allowit to be reduced in diameter during loading of the device onto acatheter. An optional needle 404, suture, T-bar 405, hollow helicalanchor 406 or screw type anchor 407 is inserted into and/or through thetissue of the pylorus 106, pyloric antrum 104 or duodenum 107 to provideadditional anchoring and securement of the intestinal bypass sleeve 111anchoring device to the pylorus 106 anatomy. The T-bar 405 is anchoredby a tensioning member 408 and cincher 409.

FIG. 30 is a sectional view of the invention herein disclosed implantedinto the pyloric antrum 104, pylorus 106, duodenal bulb 107 and duodenum112. The anchoring device is comprised of two disk-shaped expandableanchors 341 and 342 as previously disclosed in this application that areconnected to rings 352 and 353. Alternatively the disk can beconstructed from a disk and toroidal springs as previously disclosed inFIG. 14 or FIG. 7.

The rings 352 and 353 are not rigidly connected to each other.Thin-walled central membrane 351 is connected to the two rings 352 and353. Central membrane can open and close with the pylorus. Drawstring347 can be tensioned to collapse the diameter of the expandable anchorsfor removal and for loading the device onto a delivery catheter.

FIG. 31 is a sectional view of the invention herein disclosed implantedinto the pyloric antrum 104, pylorus 106, duodenal bulb 107 and duodenum112. The anchoring device is comprised of two disk-shaped expandableanchors 341, 342 as previously disclosed in this application that areconnected to a rigid central cylinder 344. The disk can be constructedfrom a disk and toroidal springs as previously disclosed in FIG. 14 orFIG. 7.

The lumen of the anchoring device has a one way anti-reflux valve 346and a flow limiter 345. Drawstring 347 can be tensioned to collapse thediameter of the expandable anchors for removal and for loading theexpandable anchor onto a delivery catheter.

FIG. 32 is a cross-sectional drawing of a delivery catheter for theinvention herein disclosed. The delivery catheter is comprised of:distal outer capsule 638, which transitions down to a smaller diameterat the proximal outer sheath 649, proximal pusher catheter 642, sleevedelivery catheter outer tube 643, sleeve delivery catheter inner tube642. There are four handles on the catheter: outer sheath handle 639,proximal pusher handle 646, sleeve delivery catheter outer tube 645 andsleeve delivery catheter inner tube 644. The implant pusher disk 650serves as a mechanical stop or means to hold stationery or push out theexpandable anchor 648 or implant from the inside of the distal outercapsule 638. The distal tip 652 provides for a flexible tip that willtrack over a guide wire. The guide wire may be inserted through thesleeve delivery catheter central lumen 651. Expandable anchor 648 andthe intestinal bypass sleeve 641 are compressed and loaded onto thedelivery catheter. The intestinal bypass sleeve 641 extends out beyondthe end of the distal outer capsule 638. The sleeve delivery catheter640 is coaxially inside the lumen of the intestinal bypass sleeve 641and mechanically retains the intestinal bypass sleeve to the end of thesleeve delivery catheter. Capsule connector 647 joins the distal outercapsule 638 to the proximal outer sheath 649.

The distal outer capsule 638 may be made from a plastic polymer such asPebax® (polyether block amide), Hytrel (polyester elastomer), nylon 12,nylon 11, nylon 6, nylon 6,6, polyethylene, polyurethane or othersuitable polymer. The distal outer sheath 638 may have an inner liningmade from a polymer with a low coefficient of friction such as PTFE. Thedistal outer capsule 638 may also have a metal re-enforcement in thewall thickness to improve the kink resistance or burst properties of theouter sheath. The metal re-enforcement may be comprised of a braidedwire mesh or a coil in the wall thickness. The metal used for the braidmay be stainless steel, Nitinol, MP35N, L605, Elgiloy or other suitablematerial. The distal outer capsule 638 length may range from 1-2 inchesin length up to full length of the catheter.

The proximal outer sheath 649 may be made from a plastic polymer such asPebax® (polyether block amide), Hytrel (polyester elastomer), nylon 12,nylon 11, nylon 6, nylon 6,6, polyethylene, polyurethane or othersuitable polymer. The proximal outer sheath 649 may have an inner liningmade from a polymer with a low coefficient of friction such as PTFE. Theproximal outer sheath 649 may also have a metal re-enforcement in thewall thickness to improve the kink resistance or burst properties of theouter sheath. The metal re-enforcement may be comprised of a braidedwire mesh or a coil in the wall thickness. The metal used for the braidmay be stainless steel, Nitinol, MP35N, L605, Elgiloy or other suitablematerial.

The proximal pusher catheter 642 may be made from a plastic polymer suchas Pebax® (polyether block amide), PEEK, Hytrel (polyester elastomer),nylon 12, nylon 11, nylon 6, nylon 6,6, polyethylene, polyurethane,polyimide, PTFE, FEP or other suitable polymer. The proximal pushercatheter 642 may have an inner lining made from a polymer with a lowcoefficient of friction such as PTFE. The proximal pusher catheter 642may also have a metal re-enforcement in the wall thickness to improvethe kink resistance or burst properties of the outer sheath. The metalre-enforcement may be comprised of a braided wire mesh or a coil in thewall thickness. The metal used for the braid may be stainless steel,Nitinol, MP35N, L605, Elgiloy or other suitable material

The sleeve delivery catheter 640 may be made from a plastic polymer suchas Pebax® (polyether block amide), PEEK, Hytrel (polyester elastomer),nylon 12, nylon 11, nylon 6, nylon 6,6, polyethylene, polyurethane orother suitable polymer. The sleeve advancement pusher 172 may have aninner lining made from a polymer with a low coefficient of friction suchas PTFE. The sleeve delivery catheter 640 may also have a metalre-enforcement in the wall thickness to improve the kink resistance orburst properties of the outer sheath. The metal re-enforcement may becomprised of a braided wire mesh or a coil in the wall thickness. Themetal used for the braid may be stainless steel, Nitinol, MP35N, L605,Elgiloy or other suitable material. The sleeve delivery catheter 640 mayhave a hollow core to allow passage over a guide wire or it may be solidwithout an opening. The sleeve delivery catheter 640 may also beconstructed of a simple tightly wound metal wire coil construction or itmay be wound from multiple wires such as Hollow Helical Strand tube madeby Fort Wayne Metals. The distal tip 652 may be molded from Pebax®,polyurethane, Hytrel, silicone or other suitable elastomer. The deliverycatheter handles may be molded or machined from metal or plastic. Theouter sheath handle 639 is attached to the proximal outer sheath 649.The outer sheath handle 639 is used to hold or retract the distal outersheath 638 and the proximal outer sheath 649 during the advancement ofthe delivery catheter into the human anatomy, and while deploying of theexpandable anchor.

FIG. 33 is an alternative embodiment of the distal outer capsule 638.The distal outer capsule has a formed tip 653 that has 6 leaflets thatbend open to allow loading or deploying of the expandable anchor. Theleaflets are preferably made from a plastic material such as PTFE orpolyethylene. The leaflets are attached to the distal outer capsule 638and can be made in a straight shape integral with the distal outercapsule 638 material and then heat formed into the final shape. Thenumber of leafs can range from about 3 to 16.

FIG. 34 is a drawing of an alternative embodiment of a tip for theinside diameter of distal outer capsule 638. Proximal pusher catheter642 extends through the length of the distal capsule 638. Proximalpusher catheter 642 is a dual lumen tubing. The first lumen 659 is foradvancement or retraction of the sleeve delivery catheter, the inflationlumen 657 is for inflating and deflating the inflatable balloon tip 654bonded at the distal end of the pusher catheter 642. A thin wallcompliant balloon tip 654 bonded onto the distal end of the proximalpusher catheter. The balloon tip 654 can be inflated or deflated throughthe side port 658 which is connected to the inflation lumen 657. Theballoon tip 654 is inflated with air, CO2, water or saline after theexpandable anchor and intestinal bypass sleeve have been loaded into thedistal outer capsule. The intestinal bypass sleeve is compressed inbetween the annular space 660 between the inside diameter of the distalouter capsule 638 and the balloon tip 654.

FIG. 35 is a drawing of an alternative embodiment of the deliverycatheter previously disclosed in FIG. 32. The implant pusher disk 650 asshown in FIG. 32 has been modified to incorporate a retention mechanism660. Spring retainer arms 661 can engage with holes in the expandableanchor 648 central cylinder. The spring retainer arms 661 can securelyhold the expandable anchor 648 and prevent the expandable anchor 648from slipping out of the distal capsule and deploying prematurely beforethe expandable is in the proper implant location. The spring retainerarms 661 can also allow the distal capsule 638 to be advanced distallyforward over a partially deployed expandable anchor 648 to resheath apartially deployed expandable anchor.

FIG. 36 is a drawing of an expandable anchor 664 and an intestinalbypass sleeve 111 attached to a retention mechanism 660 on a deploymentcatheter. The distal outer sheath 638 is pushed in direction 662 whilemaintaining tension in the direction 663 will hold the expandable anchorin position while the distal outer capsule 638 is advanced distally overthe expandable anchor 664 to re-collapse it.

FIG. 37 is a cross-sectional drawing of a portion of a delivery catheterfor the invention as previously disclosed in FIG. 32. The catheter isidentical to that disclosed in FIG. 32. The expandable anchor 648 andthe intestinal bypass sleeve 641 are compressed and loaded onto thedelivery catheter. The sleeve delivery catheter 640 is located coaxiallyinside the lumen of the intestinal bypass sleeve 641 and mechanicallyretains the intestinal bypass sleeve to the end of the sleeve deliverycatheter. The intestinal bypass sleeve 641 is wrapped in a helicaldirection around the sleeve delivery catheter by rotating the sleevedelivery catheter within the distal outer capsule 638, while fixing therotational position of distal outer capsule. This causes the intestinalbypass sleeve 641 to wrap down more compactly around the sleeve deliverycatheter and reduces the delivery profile.

FIG. 38 is a cross-sectional drawing of a portion of a delivery catheterfor the invention as previously disclosed in FIG. 32. The catheter isidentical to that disclosed in FIG. 32. The expandable anchor 648 andthe intestinal bypass sleeve 641 are compressed and loaded onto thedelivery catheter. The sleeve delivery catheter 640 is located coaxiallyinside the lumen of the intestinal bypass sleeve 641 and mechanicallyretains the intestinal bypass sleeve to the end of the sleeve deliverycatheter. The intestinal bypass sleeve 641 is loaded into the inside ofthe outer distal capsule 638 in an accordion fashion.

FIG. 39 is a drawing of an alternative embodiment of an anchor retentiondevice 666, distal outer capsule 638 and pusher tube 668. During thedeployment of expandable anchors on catheters without retention devices666 the distal outer capsule 638 is pulled back in direction 669 orretracted gradually to expose the expandable anchor 665. The pusher tube668 is held in a fixed position. The expandable anchor 665 self expandsand opens to the expanded diameter as the distal outer capsule 638 isretracted. During the retraction of the distal outer capsule 638 theexpandable anchor 665 can in some instances slide forward in a distaldirection 670 without further retraction of the distal outer capsule638. Essentially the expandable anchor 665 can self deploy withoutfurther retraction of the distal outer capsule 638, once the distalouter capsule 638 has been partially retracted. This can lead to theexpandable anchor 665 to be inadvertently deployed at the wrong implantlocation. In order to overcome this it is desirable to have theexpandable anchor 665 remain attached to the pusher tube 668 until thedistal outer capsule 638 is fully retracted. It is also desirable tohave the expandable anchor 665 remain attached to the pusher tube 668 toallow the distal outer capsule 638 to be re-advanced distally 670 tocause the expandable anchor 665 to be re-collapsed and then re-sheathedso that the position of the expandable anchor in the human body can beadjusted after the start of the deployment or alternatively theexpandable anchor can be removed from the body. Herein disclosed is aretention device 666 that provides for secure attachment of theexpandable anchor 665 to the pusher tube 668 during distal outer capsule638 retraction and allows for the distal outer capsule to be advanceddistally 670 to sheath a partially expanded anchor 665. The retentiondevice 666 is formed in a cylindrical form with an hour glass shape anannular groove 672 at the central portion. The diameter of retentiondevice 666 and the annular groove 672 is sized such that the proximalend of the expandable anchor 667 can be collapsed and the diameterreduce to allow loading inside the distal outer capsule 638. Theproximal end of the expandable anchor 667 has a larger cross sectionthan the gap 671 between the outside diameter of 666 and the insidediameter of 638, therefore the expandable anchor proximal end 667 cannotmove proximally or distally until the distal outer capsule 638 fullyretracts past the annular groove 672.

FIG. 40 is a drawing of an over the wire sleeve delivery catheter forplacing an intestinal bypass sleeve within the intestine. The sleevedelivery catheter is made from a piece of two lumen tubing 673. The twolumen tubing 673 has a circular cross section. The outside diameter 679can range from about 1 mm to 10 mm in diameter, but the diameter isabout 2.3 mm in the preferred embodiment. The guide wire lumen 675 inthe two lumen tubing 673 is sized to accommodate a guide wire (guidewire not shown) and can range in diameter from 0.5 mm to 2 mm. Therelease wire lumen 681 is sized to accommodate a release wire 677. Therelease wire 677 can slide freely within the release wire lumen 681. Thelength 678 of the sleeve delivery catheter can range from one to threemeters in length depending upon the length of the intestinal bypasssleeve 674 length that is to be delivered with the sleeve deliverycatheter. An intestinal bypass sleeve 674 is loaded over the outsidediameter of the sleeve delivery catheter. The intestinal bypass sleeve674 is secured to the sleeve delivery catheter at 683. The release wire677 is inserted through a hole in the side of the intestinal bypasssleeve 674. To deploy the sleeve the release wire is pulled in direction680 until the wire is retracted into the open position 684. Anexpandable anchor would be attached to the intestinal bypass sleeve atlocation 682 but it is not shown. The sleeve delivery catheter can havea handle attached to the proximal end 676. The two lumen tubing 673 isextruded from Pebax® (polyether block amide), PEEK, Hytrel (polyesterelastomer), nylon 12, nylon 11, nylon 6, nylon 6,6, polyethylene,polyurethane or other suitable polymer. The lumens 675 and 681 can havea liner in the lumen made from PTFE. The release wire 677 can be madefrom plastic such as PEEK or a metal such as stainless steel, MP35N,Nitinol or other suitable metal. The release wire 677 may be PTFE coatedor siliconed coat to reduce sliding friction within the lumen 681.

FIG. 41 is a drawing of a monorail sleeve delivery catheter for placingan intestinal bypass sleeve within the intestine. The sleeve deliverycatheter is made from a piece of two lumen tubing 673. The two lumentubing 673 has a circular cross section. The outside diameter 679 canrange from about 1 mm to 10 mm in diameter, but the diameter is about2.3 mm in the preferred embodiment. The guide wire lumen 675 in the twolumen tubing 673 is sized to accommodate a guide wire (guide wire notshown) and can range in diameter from 0.5 mm to 2 mm. The release wirelumen 681 is sized to accommodate a release wire 677. The release wire677 can slide freely within the release wire lumen 681. The length 678of the sleeve delivery catheter can range from one to three meters,depending upon the length of the intestinal bypass sleeve 674, which isthe length that is to be delivered with the sleeve delivery catheter. Anintestinal bypass sleeve 674 is loaded parallel to outside diameter ofthe sleeve delivery catheter. The intestinal bypass sleeve 674 issecured to the sleeve delivery catheter at 683. The release wire 677 isinserted through a hole in the side of the Intestinal bypass sleeve 674.To deploy the sleeve the release wire is pulled in direction 680 untilthe wire is retracted into the open position 684. An expandable anchorwould be attached to the intestinal bypass sleeve at location 682 but itis not shown. The sleeve delivery catheter can have a handle attached tothe proximal end 676. The two lumen tubing 673 can be extruded fromPebax® (polyether block amide), PEEK, Hytrel (polyester elastomer),nylon 12, nylon 11, nylon 6, nylon 6,6, polyethylene, polyurethane orother suitable polymer. The lumens 675 and 681 can have a liner in thelumen made from PTFE. The release wire 677 can be made from plastic suchas PEEK or a metal such as stainless steel, MP35N, Nitinol or othersuitable metal. The release wire 677 may be PTFE coated or siliconecoated to reduce sliding friction within the lumen 681.

FIG. 42 is a drawing of an alternative embodiment of an over the wiresleeve delivery catheter for placing an intestinal bypass sleeve withinthe intestine. The sleeve delivery catheter is comprised of a proximalhandle 692, an outer tube 686, an inner tube 691, a distal tip 687, anactuation knob 693 and a holder collar 688. The sleeve delivery catheterhas two coaxial tubes. The outer tube 686 connects to the actuation knob693. The inner tube 691 is connected to the proximal handle 692. Theholder collar 688 is connected to the distal end of the outer tube. Thedistal tip 687 is connected to the distal end of the inner tube 691. Theouter tube 686 and inner tube 691 can be made from Pebax® (polyetherblock amide), PEEK, Hytrel (polyester elastomer), nylon 12, nylon 11,nylon 6, nylon 6,6, polyethylene, polyurethane or other suitablepolymer. The inside lumen of outer tube 686 or the outside diameter ofinner tube 691 can have a liner or covering of PTFE. The distal tip 687can be made from a plastic such as Pebax® (polyether block amide),Hytrel (polyester elastomer), nylon 12, nylon 11, nylon 6, nylon 6,6,polyethylene, polyurethane or other suitable polymer. The sleevedelivery catheter has a guide wire lumen 694 to allow the sleevedelivery catheter to be tracked over a guide wire. The guide wire canexit at 696 for a full over the wire catheter. Alternatively the guidewire can exit the catheter at 697 for a monorail type catheter. Thedistance 689 between the distal tip 687 and holder collar 688 can beincreased or decreased by sliding the actuation knob 692 towards or awayfrom the distal tip 687 to change the distance 690. The intestinalbypass sleeve is not shown in FIG. 42, but it is attached to the sleevedelivery catheter as previously disclosed in FIG. 40 in an over-the-wiremeans. Alternatively the intestinal bypass sleeve is attached to thesleeve delivery catheter as previously disclosed in FIG. 41 in amonorail or parallel to the catheter means with the sleeve deliverycatheter not residing within the lumen of the intestinal bypass graft.An alternative embodiment of a holder collar is disclosed in 695.

Holder collars 688 and 695 are actuated and released by actuation knob692 to mechanically secure the intestinal bypass sleeve during deliveryand release the intestinal bypass sleeve from the sleeve deliverycatheter at the intended implant location.

FIG. 43 is a drawing of a delivery catheter for placing the expandableanchor and intestinal bypass sleeve within the digestive tract. A sleevedelivery catheter as previously disclosed in FIG. 42 is inserted throughthe central lumen of a delivery catheter as previously disclosed in FIG.32.

FIG. 44A is a drawing of a balloon catheter 121 that is used as a sleevedelivery catheter. The balloon is composed of the following elements:proximal hub 122, catheter shaft 124, distal balloon component 125,radiopaque marker bands 126, distal tip 127, guide wire lumen 128,inflation lumen 129. Distal balloon component 125 can be made fromsilicone, silicone polyurethane copolymers, latex, nylon 12, PET(Polyethylene terephthalate) Pebax® (polyether block amide),polyurethane, polyethylene, polyester elastomer or other suitablepolymer. The distal balloon component 125 can be molded into acylindrical shape, into a dogbone or a conical shape. The distal ballooncomponent 125 can be made compliant or non-compliant. The distal ballooncomponent 125 can be bonded to the catheter shaft 124 with glue, heatbonding, solvent bonding, laser welding or suitable means. The cathetershaft can be made from silicone, silicone polyurethane copolymers,latex, nylon 12, PET (Polyethylene terephthalate) Pebax® (polyetherblock amide), polyurethane, polyethylene, polyester elastomer or othersuitable polymer. Section A-A in FIG. 3A is a cross-section of thecatheter shaft 124. The catheter shaft 124 if shown as a dual lumenextrusion with a guide wire lumen 128 and an inflation lumen 129. Thecatheter shaft 124 can also be formed from two coaxial single lumenround tubes in place of the dual lumen tubing. The balloon is inflatedby attaching a syringe (not shown) to a luer fitting side port 130. Thesizing balloon accommodates a guide wire through the guide wire lumenfrom the distal tip 127 through the proximal hub 122. The balloon 121has two or more radiopaque marker bands 126 located on the cathetershaft to allow visualization of the catheter shaft and balloon position.The marker bands can be made from tantalum, gold, platinum, platinumiridium alloys or other suitable material.

FIG. 44B shows a rapid exchange balloon catheter 134 that is used as asleeve delivery catheter. The balloon is composed of the followingelements: proximal luer 131, catheter shaft 124, distal ballooncomponent 125, radiopaque marker bands 126, distal tip 127, guide wirelumen 128, inflation lumen 129. The materials of construction will besimilar to that of FIG. 4A. The guide wire lumen 128 does not travel thefull length of the catheter. It starts at the distal tip 127 and exitsout the side of the catheter at distance shorter than the overallcatheter length. The guide wire 132 is inserted into the ballooncatheter to illustrate the guide wire path through the sizing balloon.The balloon catheter shaft changes section along its length from asingle lumen at section B-B 133 to a dual lumen at section A-A at 124.

FIG. 45A is a drawing of the sleeve delivery catheter balloon previouslydisclosed in FIG. 44A with an intestinal bypass sleeve 800 attached tothe balloon. The intestinal bypass sleeve 800 is attached to the balloonat location 801 by a release-able means. The release-able means in thepreferred embodiment may be comprised of a loop of suture wrapped aroundthe outside of the intestinal bypass sleeve at location 801. The sutureis knotted and tied to secure the intestinal bypass sleeve at location801. The intestinal bypass sleeve 800 may be perforated by the suture atlocated 801 to increase the securement force. The balloon component 125is partially inflated to a low pressure of about one atmosphere ofpressure to secure the suture and the intestinal bypass sleeve 800 atlocation 801. Alternatively the sleeve is fastened to the balloon byband of plastic or an elastomer, such as a piece of heat shrink tubing,a cable tie, adhesive or by hook and loop fastener. The suture may bemade of polyester, nylon, polypropylene, or other suitable polymer andmay be made from a mono filament or a multifilament yarn. The intestinalbypass sleeve 800 can be arranged around the balloon catheter in acoaxial configuration as shown in section 808 or alternatively it can bearranged as shown in FIG. 45C section 809. The intestinal bypass sleeve800 is attached to the expandable anchor at location 802. The expandableanchor would be loaded into a distal outer capsule for delivery.

FIG. 45B is a drawing of the sleeve delivery catheter and intestinalbypass sleeve 800 of FIG. 45A, the distal balloon component 125 has beeninflated with air, water, saline or contrast media to a pressure highenough to expand the diameter of the balloon component 125 and to breakthe suture securement 803 of the intestinal bypass sleeve 800 from thedistal end of the sleeve delivery balloon. The pressure required tobreak the suture is in the range from 2 to 15 atmospheres. After thesuture or other means of securement is broken and the intestinal bypasssleeve 800 is released, the balloon is deflated and withdrawn from theintestinal bypass sleeve.

FIG. 45C is a drawing of the monorail sleeve delivery catheter of FIG.44B in which the intestinal bypass sleeve 806 has been attached to theballoon catheter at location 805. The securement mechanism and releasemeans are the same as previously disclosed in FIG. 45A and FIG. 45B. Theintestinal bypass sleeve 806 is not coaxial over the balloon catheter,but is delivered along side or parallel to the balloon catheter as shownin section 809. The intestinal bypass sleeve 806 is attached to theexpandable anchor at location 807. The expandable anchor would be loadedinto a distal outer capsule for delivery.

FIG. 46 is a drawing of a sleeve delivery catheter. Sleeve deliverycatheter is comprised of an outer actuation tube 810 an innernon-actuating tube 811. The outer actuating tube 810 can have a slot 814cut at the distal end to secure the tab 815 at the distal end of anintestinal bypass sleeve 812. The inner non-actuating tube 811 can havea recess 813 cut into the diameter to serve as a receptacle to hold thetab 815. The intestinal bypass sleeve 812 is secured to the distal endof the sleeve delivery catheter by inserting the tab 815 into slot 814and sliding the outer actuating tube 810 distally to close gap 817. Torelease the intestinal bypass sleeve 812 the outer actuating tube 810 isretracted to increase the gap 817 and the tab 815 is released from slot814. Alternatively the intestinal bypass sleeve can have a hole 816 atthe distal end and be secured to the outer actuated tube 810 by a pinwhich inserts through hole 816. An actuation handle is attached to theproximal ends of outer actuation tube 810 and inner non-actuating tube810, a suitable design was previously disclosed in FIG. 42. The outeractuating tube 810 and inner non-actuating tube 811 can be made frommaterial previously disclosed in FIG. 42.

FIG. 47 shows a guide wire to be used for placing expandable anchors andintestinal bypass sleeves. During the delivery of intestinal bypasssleeves, it is necessary to insert a guide wire two feet or more intothe small intestine past the pylorus into the jejunum. It can bedifficult with a conventional guide wire to advance the guide wire intothe jejunum in some patients. With conventional guide wires, there is arisk that the guide wire tip may perforate through the intestinal wallif the guide wire is advanced with a large force and the guide wire doesnot follow the natural intestinal lumen. It is desirable to have a guidewire that can easily track several feet beyond the pylorus and have lowrisk of perforating the small intestine wall. It is also desirable tohave the guide wire have a low profile when it is removed from a patientafter an expandable anchor and intestinal bypass sleeve are placed. Theguide wire is comprised of a releasable ball tip 825, an outer coil ortube 826, an inner tube 827, an outer tube handle 828, an outer tubelock 829, an inner tube handle 827 and an inner tube lock 831. The balltip can range in diameter from 3 mm to 12 mm. The ball can be made fromplastics such as PTFE, Nylon, polypropylene, polyethylene, PEEK or othersuitable material. Alternatively, the ball can be made of a metal suchas stainless steel, tantalum, titanium or other suitable material. Theouter coil or tube 826 can be made of a plastic tube, a wound wire coil,a metal tube or from helical hollow stranded tube (Fort Wayne Metals).

According to various embodiment, the outer diameter of the outer tube826 can range from 0.5 mm in diameter up to 4 mm in diameter. The lengthof the outer tube 826 can range from 1 meter to 4 meters. The inner tube827 inserts coaxially within the inner diameter of the outer tube 826.The outer tube handle 828 is secured and released from the outer tube826 by lock knob 829. The inner tube handle 830 is secured and releasedfrom the inner tube 827 by the lock knob 831. The lock knobs 829 and 831are threaded into the lock handles 828 and 830 and lock onto the outertube 826 or inner tube 827 by turning the lock into the handle. The balltip 825 is threaded onto the distal end of the inner tube 827. Asectional view of the ball 832 shows the male threads 833 on the outsidediameter of the inner tube threaded into the female threads on ball 832.The outer tube 834 has a collar 835 on the distal end. The collar 835has two pins 836 that engage in holes in the outside diameter of theball 833. The outer tube 834 and collar 835 are pushed against the balltip 832 and rotated in a counter clockwise direction, while the innertube 837 is rotated in a clockwise direction to unthread and detach theball tip from the end of the guide wire.

An alternative ball securement or release mechanism incorporates aspring disk 839. The spring disk 839 can be made from Nitinol orstainless steel. The proximal hub of the spring disk 839 is attached tothe outer tube 840. The distal hub of spring disk 839 is attached to theinner tube 841. The expanded spring disk 839 fits into a cavity insidethe ball tip 838. The diameter of the spring disk 839 can be reduced toallow the spring disk to be withdrawn from the cavity inside the ball838. To reduce the diameter of the spring disk the outer tube 840 isretracted while the inner tube 841 is advanced. This causes the springdisk 839 to elongate and the diameter of the spring disk to reduce tothe diameter of the outer tube 840.

An alternative ball securement release mechanism incorporates a tensionwire to secure and remotely release the ball from the guide wire tip.The ball tip 842 has a longitudinal socket bored into the diameter toallow outer tube 844 to extend into the ball diameter with a loose slipfit. The ball tip has a second hole drilled transversely through thediameter and a pin 843 is press fit into the transverse hole. Retentionsuture 847 is looped through the inside lumen of tube 844 around pin 843at location 846 and back through the inside lumen of tube 844 a secondtime and exits tube 844 at 845. A handle maintains the tension on thesutures 847 and 845 until the ball is detached from the guide wire. Torelease the ball the end of suture 847 is withdrawn from tube 844 andthe other end suture 845 is drawn into outer tube 844. The tensionsuture is withdrawn over pin 843 at point 846 and the ball is released.The tension suture maybe comprised of a plastic suture and made fromPTFE, polyester, Dyneema, nylon, polypropylene or other suitablepolymer. Alternatively the retention suture 847 is comprised of metalwire, cable or braided wire and is made from stainless steel, Nitinol,MP35n, L605, Elgiloy, titanium or other suitable metal.

FIG. 48A is a cross-sectional view of a portion of the digestive tractin a human body with an endoscope 701 inserted through the mouth,esophagus and stomach to the pylorus 106.

FIG. 48B is a cross-sectional view of a portion of the digestive tractin a human body with an endoscope 701 inserted through the mouth,esophagus and stomach 103 to the pylorus. A guide wire 702 is insertedthrough the working channel of the endoscope 701. The guide wire isadvanced distally in the small intestine lumen into the jejunum 113.

FIG. 49A is a cross-sectional view of a portion of the digestive tractin a human body with an endoscope inserted through the mouth, esophagusand stomach to the pylorus. The guide wire 702 as previously disclosedin FIG. 47 with a ball 703 attached to the distal end is back-loadedinto the working channel of the endoscope 701 prior to insertion of theendoscope. The guide wire 702 is advanced distally in the smallintestine lumen into the jejunum.

FIG. 49B is a cross-sectional view of a portion of the digestive tractin a human body with an endoscope inserted through the mouth, esophagusand stomach to the pylorus. The guide wire of FIG. 47 is left in placein the jejunum while the endoscope is withdrawn from the body. Theendoscope 701 is then reinserted into the stomach through the mouth andesophagus parallel to the guide wire 703, but the guide wire 703 is notin the working channel of the endoscope.

FIG. 50A is a continuation in the deployment sequence from FIG. 49B. Anexpandable anchor and intestinal bypass sleeve 704 have been loaded onto the delivery catheter. The delivery catheter and intestinal bypasssleeve 704 are advanced over the guide wire 702 through the mouth,esophagus, stomach and small intestine until the distal end of theintestinal bypass sleeve 704 reaches the desired implant location. Therelease wire FIG. 40 item 677 on the sleeve delivery catheter is thenretracted FIG. 40 680 to release the intestinal bypass sleeve 704 fromthe distal end of the sleeve delivery catheter.

FIG. 50B is a continuation in the deployment sequence from FIG. 50A. Thesleeve delivery catheter distal outer capsule 706 is partially retractedproximally to deploy or release the distal end of the expandable anchor705 from the distal outer capsule 706. The sleeve delivery catheter isthen retracted to remove it partially or fully from the digestivesystem.

FIG. 51 is a continuation in the deployment sequence from FIG. 50B. Thedistal outer capsule 706 of the delivery system is fully retracted todeploy or release the proximal end of the expandable anchor 705 from thedistal capsule. The expandable anchor 705 and the intestinal bypasssleeve 704 are now in place at the intended implant location. The ball703 on the end of the guide wire 702 is now released and left to passnaturally through the digestive tract. The ball on the end of the guidewire can alternatively be made from a bio-absorbable polymer anddissolves upon release from the guide wire. The guide wire, deliverycatheter, and endoscope are withdrawn from the human body.

FIG. 52 is a cross-sectional drawing of an alternative embodiment of adelivery catheter for the invention herein disclosed. The deliverycatheter is comprised of: distal outer capsule 707, which transitionsdown to a smaller diameter at the proximal outer sheath 717, sleevedelivery catheter 715, anchor pusher 714, and anchor pusher disk 713.Capsule connector 722 joins the distal outer capsule 707 to the proximalouter sheath 717. The distal outer capsule 707 is made from dual lumentubing. The first lumen 711 is sized to accommodate the expandableanchor and can range in diameter from 3 mm to 12 mm. The second lumen712 is sized to accommodate the sleeve delivery catheter 715 and canrange in diameter from 1 mm to 4 mm. The distal outer capsule 707 may bemade from a plastic polymer such as Pebax® (polyether block amide),Hytrel (polyester elastomer), ePTFE, PTFE, FEP, nylon 12, nylon 11,nylon 6, nylon 6,6, polyethylene, polyurethane or other suitablepolymer. The distal outer capsule 707 may have an inner lining made froma polymer with a low coefficient of friction such as PTFE. The distalouter capsule 707 may also have a metal re-enforcement in the wallthickness to improve the kink resistance or burst properties of theouter sheath. The metal re-enforcement may be comprised of a braidedwire mesh or a metal coil in the wall thickness. The wire used for there-enforcement may have a round or rectangular cross section. The metalused for the braid may be stainless steel, Nitinol, MP35N, L605, Elgiloyor other suitable material. The distal outer capsule 707 length mayrange typically from 1-3 inches in length or alternatively up to thefull length of the catheter.

The proximal outer sheath 717 is a dual lumen tube. The first lumen 720is sized to accommodate the sleeve delivery catheter and may range indiameter from 1 mm to 4 mm. The second lumen 721 is sized to accommodatethe anchor pusher 714 and may range in diameter from 1 to 4 mm size. Theproximal outer sheath 717 may be made from a plastic polymer such asPebax® (polyether block amide), PTFE, Hytrel (polyester elastomer),nylon 12, nylon 11, nylon 6, nylon 6,6, polyethylene, polyurethane orother suitable polymer. The proximal outer sheath 717 may have an innerlining made from a polymer with a low coefficient of friction such asPTFE. The proximal outer sheath 717 may also have a metal re-enforcementin the wall thickness to improve the kink resistance or burst propertiesof the outer sheath. The metal re-enforcement may be comprised of abraided wire mesh or a coil in the wall thickness. The metal used forthe braid may be stainless steel, Nitinol, MP35N, L605, Elgiloy or othersuitable material.

The anchor pusher disk 713 serves as a mechanical stop or means to holdstationery or push out the expandable anchor from the inside of thedistal outer capsule 711. The anchor pusher disk 713 can be made frommetal or plastic and it can incorporate the anchor retention features asprevious disclosed in FIG. 35 and FIG. 39.

The anchor pusher 714 may be made from a plastic polymer such as Pebax®(polyether block amide), PEEK, Hytrel (polyester elastomer), nylon 12,nylon 11, nylon 6, nylon 6,6, polyethylene, polyurethane, polyimide,PTFE, FEP or other suitable polymer. The anchor pusher 714 may have aninner lining made from a polymer with a low coefficient of friction suchas PTFE. The anchor 714 may also have a metal re-enforcement in the wallthickness to improve the kink resistance or burst properties of theouter sheath. The metal re-enforcement may be comprised of a braidedwire mesh or a coil in the wall thickness. The metal used for the braidmay be stainless steel, Nitinol, MP35N, L605, Elgiloy or other suitablematerial. Alternatively, the anchor pusher 714 may have a solid crosssection and be made from metal such as stainless steel, Nitinol, MP35N,L605, Elgiloy or other suitable material or it may have a hollow core.

The sleeve delivery catheter 715 may be designed as previously disclosedin FIG. 41, FIG. 42, FIG. 44A, FIG. 44B or FIG. 46. The sleeve deliverycatheter 715 may be made from a plastic polymer such as Pebax®(polyether block amide), PEEK, Hytrel (polyester elastomer), nylon 12,nylon 11, nylon 6, nylon 6,6, polyethylene, polyurethane or othersuitable polymer. The sleeve delivery catheter 715 may have an innerlining in lumens 720 or 721 made from a polymer with a low coefficientof friction such as PTFE. The sleeve delivery catheter 715 may also havea metal re-enforcement in the wall thickness to improve the kinkresistance.

The guide wire may be inserted through the sleeve delivery catheterlumen 718. Expandable anchor is compressed and loaded into the insidediameter 711 of the distal outer capsule 707. The intestinal bypasssleeve extends out beyond the end of the distal outer capsule 707. Thesleeve delivery catheter 715 is inserted form the proximal end of lumen720 to the distal end of lumen 720, sleeve delivery catheter 715 thentransitions from lumen 720 to lumen 712 by spanning outside the catheteracross segment 723.

The sleeve delivery catheter 715 is outside the lumen of the intestinalbypass sleeve and includes a feature adapted to mechanically retain theintestinal bypass sleeve to the end of the sleeve delivery catheter.

FIGS. 53A through FIG. 56B are a deployment sequence for an expandableanchor and intestinal bypass sleeve when deployed with the catheter.

FIG. 53A is a cross-sectional view of a portion of the digestive tractin a human body with an endoscope 701 inserted through the mouth,esophagus and stomach to the pylorus.

FIG. 53B is a cross-sectional view of a portion of the digestive tractin a human body with an endoscope inserted through the mouth, esophagusand stomach to the pylorus. A guide wire 702 is inserted through theworking channel of the endoscope 701. The guide wire is advanceddistally in the small intestine lumen into the jejunum.

FIG. 54A is a cross-sectional view of a portion of the digestive tractin a human body with an endoscope inserted through the mouth, esophagusand stomach to the pylorus. The guide wire 702 as previously disclosedin FIG. 47 with a ball attached to the distal end is back loaded intothe working channel of the endoscope 701 prior to insertion of theendoscope. The guide wire 702 is advanced distally in the smallintestine lumen into the jejunum.

FIG. 54B is a cross-sectional view of a portion of the digestive tractin a human body with an endoscope inserted through the mouth, esophagusand stomach to the pylorus. The guide wire of FIG. 47 is left in placein the jejunum while the endoscope is withdrawn from the body. Theendoscope 701 is then reinserted into the stomach through the mouth andesophagus parallel to the guide wire 702, but the guide wire 702 is notin the working channel of the endoscope.

FIG. 55 is a continuation in the deployment sequence from FIG. 54B. Anexpandable anchor and intestinal bypass sleeve 704 have been loaded onto a delivery catheter. The delivery catheter and intestinal bypasssleeve 704 are advanced over the guide wire 703 through the mouth,esophagus, stomach and small intestine until the distal end of theintestinal bypass sleeve 704 reaches the desired implant location. Thesleeve delivery catheter 715 is parallel to (along the outside surface)of the intestinal bypass sleeve 674. The release wire FIG. 40 item 677on the sleeve delivery catheter is then retracted FIG. 40 in thedirection 680 to release the intestinal bypass sleeve 704 from thedistal end of the sleeve delivery catheter. The ball on the end of theguide wire is now released and left to pass naturally through thedigestive tract. The ball on the end of the guide wire can alternativelybe made from a bio-absorbable polymer and dissolves upon release fromthe guide wire.

The guide wire and sleeve delivery catheter are now removed from thebody.

FIG. 56A is a continuation in the deployment sequence from FIG. 55A. Thesleeve delivery catheter distal outer capsule 707 is partially retractedproximally to deploy or release the distal end of the expandable anchor705 from the distal outer capsule 707.

FIG. 56B is a continuation in the deployment sequence from FIG. 56A. Thedistal outer capsule 706 of the delivery system is fully retracted todeploy or release the proximal end of the expandable anchor 705 from thedistal capsule. The expandable anchor 705 and the intestinal bypasssleeve 704 are now in place at the intended implant location. Thedelivery catheter and endoscope 701 are withdrawn from the human body.

FIG. 57 is a drawing of a removal catheter for removing an expandableanchor and intestinal bypass sleeve from the human body. The removalcatheter is comprised of a recovery outer tube 724, an outer tubeconnector 726, proximal outer tube 725, snare catheter 727, and a snareloop 729. An expandable anchor 733 as was previously disclosed in FIG. 7has a proximal disk 731 and a distal disk 732. The expandable anchor 733is shown without a polymer covering or without an intestinal bypasssleeve attached. The expandable anchor 733 is implanted in thegastrointestinal tract. To remove the expandable anchor the removalcatheter is advanced through the anatomy to the implant location. Thesnare loop 729 is placed around the ball 730. The snare loop 729 isdrawn into the snare recovery catheter 728 to close the snare loop 729diameter and to apply tension onto the ball 730. The closed snare loop729 and ball 730 is drawn inside of the recovery outer tube 724, thiscauses the proximal disk 731 to contact the distal end of the recoveryouter tube. The drawstring in the proximal disk 731 is tensioned withfurther withdrawl of the snare loop and snare recovery catheter withinthe proximal outer tube. The tension on the drawstring causes theproximal disk 731 to compress in diameter and the proximal end of theexpandable anchor is captured 736 within the recovery outer tube 724.Continued retraction on the snare catheter 728 and snare loop 729 wouldcause the distal disk 732 of the expandable anchor 723 to compress indiameter and to be pulled inside of the recovery outer tube until theentire expandable anchor 733 is re-sheathed. An alternative embodimentof the snare loop 729 is a simple hook 733 to grab a loop of suture orball as previously disclosed. An alternative embodiment of the recoveryouter tube 724 is to use an endoscope hood 734 press-fit onto the end ofan endoscope 735. The snare catheter 729 and snare recovery catheter 728would be used through the working channel of the endoscope to grab theball 730 and tension the draw sting to collapse the proximal disk andpull the expandable anchor into the endoscope hood.

FIG. 58 is a drawing of a monorail type eyelet 740 that can be used onthe end of an endoscope 737. The eyelet 740 has two lumens. Lumen 742 issized to be a loose fit (sliding fit) on the outer diameter of theproximal outer tube 649 as shown in FIG. 43 of a delivery catheter foran expandable anchor. Lumen 741 is sized to be a tight or friction fiton the end of an endoscope 737. When implanting expandable anchorswithin the human body it is sometimes difficult to navigate the deliverycatheter to the required path in the pyloric canal. It is desirable tobe able to removably couple the end of the endoscope to the deliverycatheter and advance the distal end of the endoscope by sliding theeyelet 740 down the proximal outer tube 739 from location 743 to 744.With the distal end of the endoscope near the distal outer capsule theendoscope 737 steering mechanism can be used to advance the catheterthrough tortuous anatomy and across the pylorus.

FIG. 59 is a drawing of a monorail type eyelet 745 that can be attachedto a distal outer capsule. The eyelet 745 has two lumens. Lumen 749 issized to be a loose fit (sliding fit) on the outer diameter of anendoscope 737. Eyelet 745 can be made from metal or plastic. Eyelet 745can have a liner made from PTFE in lumen 749. Lumen 741 is sized to be atight or friction fit on or bonded onto a distal outer capsule. Whenimplanting expandable anchors within the human body it is sometimesdifficult to navigate the delivery catheter to the required path in thepyloric canal. It is desirable to be able to removably couple the end ofthe endoscope to the delivery catheter and advance the distal end of theendoscope by sliding the eyelet 745 down an endoscope 737 from location746 to 747. With the distal end of the endoscope near the distal outercapsule the endoscope 737 steering mechanism can be used to advance thecatheter through tortuous anatomy and across the pylorus.

FIG. 60 is an expandable anchor 751 and an intestinal bypass sleeve 111which is implanted across a pylorus 105 and into the duodenum 112. Anexternal band 750 has been laparoscopically implanted around the outsideof the pylorus 105 prior to placement of the expandable anchor as waspreviously disclosed in co-pending U.S. patent application Ser. No.13/298,867, filed Nov. 17, 2011. The external band 750 providesadditional radial stiffness to the pyloric tissue and increases thesecurement force or required force to displace the expandable anchor 751from within the pylorus 106.

FIG. 61 is a cross-sectional view of a portion of the digestive tract ina human body. An intestinal bypass sleeve 111 is implanted in theduodenum 112 from the pylorus 106 to the ligament of Treitz 109. Thesleeve is held in place at the pylorus 106 by expandable anchors 410that anchor on the pylorus 106. Optional secondary expandable anchors411 anchor the intestinal bypass sleeve 111 at additional locations inthe duodenum 112 and jejunum 113. An expandable anchor 412 with ananti-reflux valve is implanted at the gastroesophageal (GE) junction 102to help resolve gastroesophageal reflux disease (GERD). Referencenumbers 414, 415, 416, 417, 418 and 419 denote valve designs that havefrom two to seven flaps in the valve and may be used for the anti-refluxdevice 413.

FIG. 62 is a drawing of a handle set for a delivery catheter aspreviously disclosed in FIG. 52. The handle set is comprised of a moldedhandle housing 752, deployment slide 754, slide lock 753, proximal outertube 717, sleeve delivery catheter proximal end 715 and sleeve deliverylock clip 758. The handle components can be made from plastic such aspolycarbonate, ABS, PEEK, Nylon, PET, PBT or other suitable polymer ormetal. The handle housing is made in a two piece clam shellconfiguration. The proximal outer sheath 717 is attached the deploymentslide 754. The anchor pusher 714 is fixed to the handle housing 752. Toretract the distal outer capsule 707 the slide lock 753 is removed fromthe handle housing 752, the deployment slide 754 which is bonded to theproximal outer tube 717 is retracted. The anchor pusher is fixed to thehandle housing, so the proximal end of the expandable anchor isstationery as the distal outer capsule retracts with the proximal outertube to unsheath the distal end of the expandable anchor. Deployment ofthe expandable anchor occurs as the deployment slide is moved fromposition 756 to 757. The sleeve delivery catheter can be secured to thehandle housing with a snap fit feature at 758.

A guide wire can be inserted through the catheter and handle set at 759.

FIG. 63 is an additional view of the handle disclosed in FIG. 62.

FIG. 64 is an additional view of handle disclosed in FIG. 62.

Various modifications and additions can be made to the exemplaryembodiments discussed without departing from the scope of the presentinvention. For example, while the embodiments described above refer toparticular features, the scope of this invention also includesembodiments having different combinations of features and embodimentsthat do not include all of the described features. Accordingly, thescope of the present invention is intended to embrace all suchalternatives, modifications, and variations as fall within the scope ofthe claims, together with all equivalents thereof.

1. A system for delivery and implantation of a gastrointestinal devicewithin one or more of a pyloric antrum, a pylorus, a duodenal bulb, aduodenum, and a jejunum of a patient's gastrointestinal tract, thesystem comprising: an anchor having a collapsed configuration fordelivery and an expanded configuration for anchoring within one or moreof the pyloric antrum, the pylorus, and the duodenum; an intestinalbypass sleeve coupled to and extending from an end of the anchor; ananchor delivery device having a distal outer capsule coupled to aproximal outer sheath, both the outer capsule and the proximal outersheath having a first lumen and a second lumen, wherein the first lumenis sized and configured to retain the anchor in the collapsedconfiguration; and a sleeve delivery catheter slidably disposed withinthe second lumen, the sleeve delivery catheter having a longitudinalguide wire lumen sized and shaped to accept a guide wire, the sleevedelivery catheter having a sleeve coupling feature for releasablycoupling to the intestinal bypass sleeve.
 2. The delivery device ofclaim 1 wherein the anchor is self-expanding such that upon deploymentfrom the outer capsule the anchor assumes the expanded configuration. 3.The delivery device of claim 1 wherein the distal outer capsule of theanchor delivery device has a first diameter and the proximal sheath hasa second diameter, smaller than the first diameter, further wherein thefirst lumen has a diameter of from about 3 mm to about 12 mm and thesecond lumen has a diameter of from about 1 mm to about 4 mm.
 4. Thedelivery device of claim 1 wherein the proximal sheath has a first lumenin communication with the first lumen of the distal outer capsule and asecond lumen in communication with the second lumen of the distal outercapsule.
 5. The delivery device of claim 4 further comprising an anchorpusher having a anchor contact feature and an elongated pusher, whereinthe anchor contact feature is sized and shaped to fit within the firstlumen and to contact the anchor and the elongated pusher is configuredto fit within the first lumen of the proximal sheath.
 6. The deliverydevice of claim 4 wherein the distal outer capsule is made from apolymer selecting from the group including: a polyether block amide, apolyester elastomer, a PTFE, an FEP, a nylon, a polyethylene or apolyurethane.
 7. The delivery device of claim 1 wherein the distal outercapsule has an inner lining made from PTFE and a length of from about 1to about 3 inches.
 8. The delivery device of claim 5 wherein the anchorcontact feature includes a retention feature for releasably couplingwith the anchor.
 9. The delivery device of claim 1 wherein the sleevecoupling feature of the sleeve delivery catheter is a loop sized toextend around an outside diameter of the intestinal bypass sleeve.
 10. Asystem for delivery and implantation of a gastrointestinal device withinone or more of a pyloric antrum, a pylorus, a duodenal bulb, a duodenum,and a jejunum of a patient's gastrointestinal tract, the systemcomprising: an anchor having a collapsed configuration for delivery andan expanded configuration for anchoring within one or more of thepyloric antrum, the pylorus, and the duodenum; an intestinal bypasssleeve coupled to and extending from an end of the anchor; an anchordelivery catheter having an anchor capsule coupled to a proximal outersheath, both the capsule and the proximal outer sheath having a centrallongitudinal lumen, wherein a diameter of the capsule portion of thecentral lumen is sized and configured to retain the expandable anchor inthe collapsed configuration; and a pusher catheter slideably disposedwithin the central longitudinal lumen of the anchor delivery catheter,the pusher catheter having a coupling feature disposed within the anchorcapsule and the pusher catheter defining an internal lumen; wherein thecoupling feature is adapted to engage the anchor such that the couplingfeature is operable to deploy the anchor from the anchor capsule; anouter sheath delivery catheter slideably disposed partially within theinternal lumen of the pusher catheter and having a distal portionextending distal to the distal end of the anchor delivery catheter, thesleeve delivery catheter having an internal lumen; and an inner sheathdelivery catheter slideably disposed within the internal lumen of theouter sheath delivery catheter, wherein the inner sleeve deliverycatheter has a sleeve retention feature disposed at or near a distalend.
 11. The system of claim 10 further comprising a handle, the handleincluding an actuation handle coupled to a proximal end of each of theanchor delivery catheter, the pusher catheter, the outer sheath deliverycatheter, and the inner sheath delivery catheter.
 12. The system ofclaim 10 wherein the inner sheath delivery catheter includes a flexibletip adapted to track over a guide wire.
 13. The system of claim 10wherein the distal outer capsule has a distal tip having a plurality ofmovable leaflets configured to allow loading and deploying of theexpandable anchor.
 14. The system of claim 10 wherein the couplingfeature of the pusher catheter includes a retention mechanism forreleasably attaching to the expandable anchor.
 15. The system of claim14 wherein the coupling feature includes a plurality of spring retainerarms adapted to retain the expandable anchor such that it resists theanchor from slipping out of the distal capsule.
 16. A gastrointestinaldevice for implanting within one or more of a pyloric antrum, a pylorus,a duodenal bulb, a duodenum, and a jejunum of a patient'sgastrointestinal tract, the implant comprising: an expandable structureincluding a proximal portion and a distal portion coupled by a centralcylinder having a diameter capable of fitting within the pylorus andhaving a length greater than a width of the pylorus; wherein each of theproximal portion and the distal portion includes a toroidal elementcoupled to the central cylinder by a plurality of control arms; amembrane coupled to and covering at least a portion of one of theproximal portion and the distal portion of the expandable structure; andan intestinal bypass sleeve coupled to at least one of the proximal anddistal portions of the expandable structure and having a lengthsufficient to extend at least partially into the duodenum; wherein, inthe expanded configuration, the toroidal element of the proximal portionhas a diameter larger than a maximum opening diameter of the pylorus andfurther wherein, in the expanded configuration, the toroidal element ofthe distal portion has a diameter larger than a maximum opening diameterof the pylorus.
 17. The gastrointestinal device of claim 16 wherein thecentral cylinder portion includes an anti-reflux valve adapted forpreventing reflux of the duodenal contents back into the stomach. 18.The gastrointestinal device of claim 16 further including a supplementalsecurement mechanism for securing the device to the pylorus or thestomach, the supplemental securement mechanism including one or more ofthe following: a suture, a T-bar, a hook, a barb and a screw-typeanchor.
 19. The gastrointestinal device of claim 16 wherein theintestinal bypass sleeve has a length sufficient to extend at leastpartially into a jejunum of the patient's gastrointestinal tract. 20.The gastrointestinal device of claim 16 wherein the control arms have anexpanded configuration extending generally parallel to a longitudinalaxis of the device and the control arms including a first end coupled tothe central cylinder at a first radial position and a second end coupledto the toroidal element at a second radial position.
 21. Thegastrointestinal device of claim 20 wherein each of the control armsinclude a corresponding eyelet near the second end and further whereinthe toroidal element is coupled to each of the corresponding eyelets.22. The gastrointestinal device of claim 16 wherein at least one of thetoroidal elements is formed from a coiled wire into a toroidal-shapedspring have a central axis and further wherein the ends of the wire arefastened with a spring joiner.
 23. The gastrointestinal device of claim16 further comprising a drawstring extending along the central axis ofat least one of the toroidal-shaped springs, the drawstring operable toreduce the diameter of the toroidal element.